TAbS

TAbS

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Record category	Entry ID	Status check date	INN	Drug code(s)	Brand name	MAb sequence source	General Molecular Category	Format, general category	Format details	Target(s)	Isotype (Fc)	Light chain isotype	Linker	Ave. DAR	Conjugated moiety	Description	Discovery method	Anticipated events	Most advanced stage of development	Status	Start of clinical phase	Start of first Phase 2	Start of first Phase 3	Indications of clinical studies	Primary therapeutic area	Company	Licensee/Partner	Comments	Factors to discontinuation	Initial approval year	FDA submission date	US approval date	US product name	Approved indications	Company address	Company country	Company region	Company website
Approved	YABS0011	08/04/2020	Secukinumab	AIN457	Cosentyx	mAb human	Naked monospecific	Full length Ab	None	IL-17A	IgG1	kappa	None	None	None	None	Transgenic mouse (Medarex/BMS)	None	Approved EU, US, Japan, Australia	Active	07/02/2005	—	05/15/2009	Atopic dermatitis, Rheumatoid Arthritis, Plaque-type Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis, Multiple Sclerosis, Crohn's Disease, Uveitis, Asthma	Immune-mediated / inflammatory disorders	Novartis Pharmaceuticals	None	Phase 3 in Lupus Nephritis not yet recruiting as of 11/29/2019. BLA submitted in October 2013; listed by EMA as under review as of December 5, 2013. PDUFA date Oct 2014. Approved in Japan 12/26/2014; approved 1/21/2015 in US; also approved in EU in 2015	None	2014	10/24/2013	01/21/2015	Secukinumab	US 2023: Treatment of adults with moderate-to-severe hidradenitis suppurativa Psoriasis, Psoriatic Arthritis, Axial Spondyloarthritis; April 29, 2020: European Commission approved Cosentyx® (secukinumab) for the treatment of adult patients with active non-radiographic axial spondyloarthritis. FDA also approved Cosentyx (secukinumab) for active non-radiographic axial spondyloarthritis; July 2020: European Commission granted the approval for Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <18 years.	Basel, Switzerland	Switzerland	Europe	https://www.novartis.com/contacts
Approved	YABS0012	10/04/2024	Cadonilimab	AK104	开坦尼®	mAb humanized	Bispecific	Full length Ab	None	PD-1, CTLA-4	IgG1	kappa	None	None	None	Immune checkpoint inhibitor. Described as a PD-1 bispecific on company website. Tetrameric; derived from TETRABODY technology. Anti-PD1 antibody with additional 2 binding scFv-derived sites for CTLA-4 attached to termini of Fc. Mutations (L235A/L236A/G238A) were introduced into the Fc region to eliminate binding to FcγRs and C1q.	None	None	Approved China	Active	10/03/2017	01/13/2019	—	Pancreatic cancer, Clear Cell Renal Cell Carcinoma, Non-small cell lung cancer, MSI-H/dMMR Solid Tumor, Cervical cancer, Hepatocellular carcinoma, peripheral T-cell lymphoma, Melanoma, Gastric or Gastroesophageal Junction Adenocarcinoma, Solid tumors	Cancer	Akesobio Australia Pty Ltd	None	Sep 2024: Adenocarcinoma Of The Gastroesophageal Junction, Gastric Cancer is approved for China on Sep 30, 2024 June 29 2022: Akeso Biopharma Inc. announced that its PD-1/CTLA-4 bi-specific antibody开坦尼® (Candonilimab injection, AK104) has received marketing approval from China Medical Products Administration (NMPA), for the treatment of relapsed or metastatic cervical cancer (R/M CC) patients who progressed on or after platinum-based chemotherapy. Aug 2021: The Company has received the approval from the National Medical Products Administration of the People’s Republic of China (‘‘China’’) to initiate a phase III pivotal registrational clinical trial for the global first-in-class novel drug Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and development code: AK104), an immuno-oncology therapy independently developed by the Company, in combination with oxaliplatin and capecitabine (‘‘XELOX’’) versus placebo in combination with XELOX for first-line treatment of advanced gastric adenocarcinoma or gastroesophageal junction cancer (clinical registration number: CTR20211567) and the national researchers’ conference has been successfully held. https://www.akesobio.com/en/media/akeso-news/21-8-3/ Company expects to file NDA in 2H 2021 (Slide 15, https://www.akesobio.com/media/1405/akesoplus2020plusarpluspresentation_ve-website2.pdf) for cervical cancer. The FDA has granted Fast Track Designation to AK104 for the treatment of advanced cervical cancer; Feb 2021 AK 104 receives Orphan Drug status for Cervical cancer (Stage IA2-IV) in USA In May 2020, AK104 obtained approval from NMPA to initiate a registrational trial for third-line treatment of patients with metastatic nasopharyngeal carcinoma. NCT04444167 Phase 1/2 study in hepatocellular carcinoma started in June 2020, and NCT04444141 Phase 1/2 study in peripheral T-cell lymphoma started in May 2020. NCT04380805 Phase 2 study in cervical cancer started July 2020. In January 2020, the company received the written consent from the FDA regarding the overall study design of a planned registrational trial of AK104 (PD-1/CTLA4) in the U.S. for 2L/3L cervical cancer patients and for potentially submitting NDA application to the FDA for cervical cancer via the accelerated approval pathway. Jan 2020: IND filed to start studies in cervical cancer. NCT04220307 Phase 2 in Metastatic Nasopharyngeal Carcinoma not yet recruiting as of first posting on Jan 7 2020. NCT04172454 Phase 1/2 in melanoma not yet recruiting as of Dec 20, 2019. NCT03852251 Phase 1/2 study started in January 2019. NCT03261011 Phase 1 study started in October 2017 still recruiting as of Aug 2018.	None	2022	—	—	Cadonilimab	None	Address : 17/F, HWT Tower, No. 40, City Road Southbank, VIC 3006, Australia	Australia	Australia	https://www.akesobio.com/en/about-us/contact-us/
Approved	YABS0013	11/25/2024	Penpulimab	AK105	ANNIKO, 安尼可®	mAb humanized	Naked monospecific	Full length Ab	None	PD-1	IgG1	kappa	None	None	None	Immune checkpoint modulator. AK105 is a humanized IgG1 mAb that blocks PD-1 binding to PD-L1 allowing T-cells to recognize and kill tumor cells. Key attributes of AK105 include antibody engineering to eliminate Fc mediated effector function, and a slower off-rate on antigen binding resulting in improved receptor occupancy (https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.e14006?af=R)	None	Regulatory review in US	Approved China	Active	12/22/2017	—	11/27/2018	Hodgkin's disease, Hepatocellular carcinoma, MSI-H or dMMR Advanced Solid Tumors, Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors (single Phase 2 study); Hepatocellular Carcinoma, Non-small cell lung cancer, Nasopharyngeal Carcinoma, solid tumors	Cancer	Akesobio Australia Pty Ltd	Specialised Therapeutics Asia Pte Ltd, Sino Biopharm	Nov 2024: Akeso, Inc., announced that the National Medical Products Administration (NMPA) of China has accepted its supplemental new drug application (sNDA) for penpulimab, a differentiated PD-1 monoclonal antibody, in combination with anlotinib for the first-line (1L) treatment of advanced hepatocellular carcinoma (HCC). This marks penpulimab's fifth indication, following its approval for first line treatment of squamous non-small cell lung cancer, first line and third-line or further treatment for metastatic nasopharyngeal carcinoma, and third-line treatment of relapsed or refractory classical Hodgkin lymphoma. The differentiated clinical value of the penpulimab combination therapy is expected to offer a more effective solution for patients with liver cancer. Apr 2023: Specialised Therapeutics Asia Pte Ltd will partner with CTTQ-Akeso (Shanghai) Biomed. Tech. Co., Ltd. (CTTQ-Akeso)(jointly established by Akeso, Inc. (9926.HK, Akeso) and Chia Tai Tianqing Pharmaceutical Group Co., Ltd. to commercialise a new immuno-oncology therapy in Australia, Singapore and across Southeast Asia. The therapy ANNIKO® (penpulimab) is an anti-PD1 monoclonal antibody currently under regulatory review by the US FDA for nasopharyngeal carcinoma – a difficult to treat form of head and neck cancer. January 16, 2023: Anniko® (penpulimab), co-developed by the Company with Sino Biopharmaceutical Limited, combined with chemotherapy as the first line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC) has been granted marketing approval by the National Medical Products Administration (NMPA) of the People’s Republic of China August 5, 2021 I Akeso, Inc. announced that the anti PD-1 monoclonal antibody drug Penpulimab monoclonal antibody injection co-developed by the Company with Sino Biopharmaceutical Limited, has obtained marketing approval by the National Medical Products Administration of China, for treatment of patients with relapsed or refractory ("r/r") classic Hodgkin's lymphoma ("cHL") after at least second-line systemic chemotherapy treatment. Penpulimab has been granted Breakthrough Therapy, Orphan Drug (Feb 2021) and Fast Track designations by the FDA for the treatment of metastatic nasopharyngeal carcinoma. May 24, 2021: Akeso, Inc. announced that Penpulimab (AK105), an PD-1 monoclonal antibody drug co-developed by the Company with Sino Biopharmaceutical Limited, has submitted a Biologics License Application to the FDA for third-line treatment of metastatic nasopharyngeal carcinoma. Penpulimab has already obtained breakthrough therapy designation and fast track designation from the FDA for third-line treatment of metastatic nasopharyngeal carcinoma. Penpulimab's BLA submitted to the FDA will be reviewed under the new policy of RTOR, which aims to accelerate the process of drug approval. RTOR is a major and innovative new oncology drug approval policy issued by the Oncology Center of Excellence ("OCE") of the FDA. Company update of Aug 2020 indicates NDA was submitted. Silde 22, https://www.akesobio.com/media/1306/akeso-2020-interim-results-presentation.pdf ◼ Single-arm registrational trials for Penpulimab for the treatment of cHL and NPC ◼ NDA filed for 3L R/R cHL in May 2020 ◼ Expected to file NDA for ≥3L NPC in 1H 2021 NCT04344158 Phase 3 in hepatocellular carcinoma not yet recruiting when posted on April 14, 2020. In September 2019, the company completed the patient enrolment of a Phase II registrational trial to evaluate penpulimab (AK105) (PD-1) for the treatment of 3L relapsed or refractory classical Hodgkin’s lymphoma (cHL), following the enrolment of the first patient in January 2019 and obtaining the pivotal trial status granted by the CDE. They expect to submit an NDA to the NMPA around mid-2020. NCT03866980 and NCT03866993 Phase 3 studies in lung cancer recruiting as of Nov and Dec 2018, respectively. NCT04172571 Phase 2 in liver cancer. NCT03352531 Phase 1 study	None	2021	—	—	Penpulimab	None	Address : 17/F, HWT Tower, No. 40, City Road Southbank, VIC 3006, Australia	Australia	Australia	https://www.akesobio.com/en/about-us/contact-us/
Approved	YABS0014	01/30/2022	Eptinezumab	ALD403	VYEPTI	mAb humanized	Naked monospecific	Full length Ab	None	CGRP	IgG1	kappa	None	None	None	Humanized rabbit antibody; proprietary yeast expression system. Aglycosylated; no FcgammaRII or III binding, reduced FcgammaR1 binding. Half-life = 28 days	Rabbit B cell derived	None	Approved EU, US, Australia	Active	04/15/2012	03/15/2013	11/15/2016	Migraine prevention	Neurological disorders	Lundbeck	None	January 24, 2022 I H. Lundbeck A/S (Lundbeck) announced that the European Commission has granted marketing authorization for Vyepti® (eptinezumab) in the European Union (EU) for the prophylactic treatment of migraine in adults who have at least four migraine days per month. Launch anticipated in Q1 2020. Oct 2019: Lundbeck has completed its takeover of US drug developer Alder BioPharmaceuticals. Feb. 22, 2019: Alder BioPharmaceuticals, Inc. today announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for eptinezumab. Eptinezumab is an investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide (CGRP) and is Alder’s lead commercial candidate. If the BLA submission is accepted and the FDA grants approval of eptinezumab, Alder will be on track for a Q1 2020 commercial launch. Lundbeck acquired Alder Biopharmaceuticals, Inc. in 2019. Jan 2018: Teva Pharmaceutical Industries Ltd. granted the company rights to IP related to eptinezumab (IV ALD403). Alder also announced that the migraine prevention candidate met the primary endpoint in a second Phase III trial. Planned timing for the submission of the Company's Biologics License Application (BLA) to the FDA remains the second half of 2018. NCT01579383 Phase 1 started in April 2012.	None	2020	02/21/2019	02/21/2020	Eptinezumab, eptinezumab-jjmr	Preventive treatment of migraine in adults	Ottiliavej 9 2500 Valby Denmark	Denmark	Europe	https://www.lundbeck.com/global/about-us
Approved	YABS0015	02/06/2019	Caplacizumab	ALX-0081, ALX-0681	Cablivi	mAb humanized	Naked monospecific	Fragment	sdAb, VHH-VHH	von Willebrand factor	None	None	None	None	None	VH-linker-VH fragment of Camelidae antibody; bivalent, no half-life extension	Camelid-derived; Phage display library	None	Approved EU, US, Japan	Active	02/15/2007	09/01/2009	10/01/2015	Acquired Thrombotic Thrombocytopenic Purpura, Unstable Angina; Non-ST Segment Elevation Myocardial Infarction (NSTEMI); Stable Angina (Associated With High Risk PCI), Thrombotic Thrombocytopenic Purpura	Cardiovascular / hemostasis disorders	Sanofi	None	Feb 6 2019: The U.S. Food and Drug Administration today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura. Sep 3 2018. Sanofi said the European Commission approved Cablivi caplacizumab to treat rare blood clotting disorder acquired thrombotic thrombocytopenic purpura (aTTP). The company also revealed Monday that FDA accepted and granted Priority Review to its BLA for the drug; the PDUFA date is Feb. 6, 2019. Sanofi expects to file BLA in Q3 2018. Jan 2018: Ablynx acquired by Sanofi. July 2017: Ablynx's caplacizumab as a treatment for patients with acquired thrombotic thrombocytopenic purpura has been granted fast-track status by the FDA. MAA for acquired thrombotic trombocytopenic purpura submitted in Feb 2017. Company expects to submit BLA in 2018. NCT02553317 Phase 3 recruiting as of Oct 2015. The ability of caplacizumab to rapidly inhibit the formation of small blood clots, resulting in the more rapid restoration of normal platelet counts and an important reduction in exacerbations, was well demonstrated in the Phase II TITAN study. Based on the clinical effect seen in this TITAN study, we are planning to submit caplacizumab for conditional approval to the European Medicines Agency (EMA) in 2017. We now look forward to enrolling 92 patients into our Phase III “HERCULES” study which we plan to have completed by the end of 2017 to support a BLA filing in the United States in 2018. Orphan designation in US and EU.	None	2018	06/06/2018	02/06/2019	Caplacizumab, caplacizumab-yhdp	Acquired thrombotic thrombocytopenic purpura	Paris, France	France	Europe	https://www.sanofi.us/en/contact-us
Approved	YABS0016	05/10/2023	Ravulizumab	ALXN1210	Ultomiris	mAb humanized	Naked monospecific	Full length Ab	None	Complement C5	IgG2/4	kappa	None	None	None	Next-generation Soliris candidate; a longer-acting anti-C5-antibody suitable for monthly dosing; uses Xencor Xtend technology. Ravulizumab (ALXN1210) differs from eculizumab by 4 amino acid substitutions, and like eculizumab is a complement component C5 inhibitor. Two of the amino acid substitutions are M428L and N434S (LS mutation) in the Fc region; these modulate the affinity to FcRn. The remaining two amino acid substitutions are in the complementarity-determining region; these substitutions modulate the affinity to the antigen.	None	None	Approved EU, US, Japan, Australia	Active	08/15/2014	11/15/2015	09/15/2016	Neuromyelitis Optica Spectrum Disorder, Generalized myasthenia gravis, Paroxysmal Nocturnal Hemoglobinuria, Atypical Hemolytic Uremic Syndrome	Immune-mediated / inflammatory disorders	AstraZeneca	None	AstraZeneca acquired Alexion (formerly Syntimmune) in 2021. EU approval announced July 3, 2019. Phase 3 study in generalized myasthenia gravis started in April 2019. BLA submission announced June 19, 2018; The submission uses a rare disease priority review voucher, which designates the BLA for an expedited eight-month review by the FDA. Company plans global regulatory filings in the U.S. and EU in mid-2018, followed by Japan later in the year. US orphan designation for hemolytic uremic syndrome. July 2017: Enrollment is complete in a Phase 3 trial comparing ALXN1210 administered intravenously every eight weeks to Soliris in complement inhibitor treatment-naive patients with PNH. Alexion expects to report data from this study in the second quarter of 2018. Alexion initiated a Phase 3 PNH Switch study of ALXN1210 administered intravenously every eight weeks compared to patients currently treated with Soliris in the second quarter of 2017. The Company expects to complete enrollment in this study in the third quarter of 2017. Patients are being dosed in a Phase 3 trial with ALXN1210 administered intravenously every eight weeks in complement inhibitor treatment-naive adolescent and adult patients with aHUS. Enrollment is expected to be complete in early 2018. Alexion expects to initiate a Phase 3 trial of ALXN1210 in pediatric patients with aHUS in the third quarter of 2017. ALXN1210, a longer-acting anti-C5 antibody designed to treat paroxysmal nocturnal hemoglobinuria, has received orphan drug status from the FDA and EMA. NCT02946463 Phase 3 recruiting as of Oct 2016. Start of Phase 1 announced Jan 29, 2015. NCT05288660 Phase 1 started in Aug 2014.	None	2018	06/18/2018	12/21/2018	Ravulizumab, ravulizumab-cwvz	May 10, 2023 I Ultomiris (ravulizumab) has been approved in the European Union (EU) for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder. European Commission has approved ULTOMIRIS® (ravulizumab)—the first and only long-acting C5 complement inhibitor administered every eight weeks*—for the treatment of adults and children with a body weight of 10 kg or above with atypical hemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve or have received SOLIRIS® (eculizumab) for at least three months and have evidence of response to eculizumab. ULTOMIRIS is approved in the United States (U.S.), European Union (EU) and Japan as a treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH) and in the U.S. for atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adult and pediatric (one month of age and older) patients. Ultomiris was approved in the US in April 2022 and Japan in August 2022 for certain adults with generalised myasthenia gravis. Sep 2022: Ultomiris (ravulizumab) has been approved in Europe as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.	Cambridge, United Kingdom	United Kingdom	Europe	https://www.astrazeneca.com/our-company/contact-us.html
Approved	YABS0017	02/20/2019	Evolocumab	AMG 145	Repatha	mAb human	Naked monospecific	Full length Ab	None	PCSK9	IgG2	lambda	None	None	None	None	Transgenic mouse (Xenomouse)	None	Approved EU, US, Japan, Australia	Active	07/01/2009	—	01/15/2012	Hypercholesterolemia and High Risk for Cardiovascular Events, homozygous familial hypercholesterolemia	Metabolic disorders	Amgen	Astellas	Partnership with Astellas for marketing in Japan. Approved in EU on July 22, 2015; approved in US on Aug 27, 2015	None	2015	08/27/2014	08/27/2015	Evolocumab	High cholesterol. REPATHA is indicated: to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease; as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C); as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.	Thousand Oaks, California, United States	United States of America	North America	https://www.amgen.com/
Approved	YABS0018	04/03/2018	Denosumab	AMG 162	Prolia, XGEVA	mAb human	Naked monospecific	Full length Ab	None	RANK-L	IgG2	kappa	None	None	None	None	Transgenic mouse	None	Approved EU, US, Japan, Australia	Active	07/01/2001	07/02/2003	08/10/2004	Osteoporosis, Breast Cancer With Bone Metastasis	Skeletal disorders	Amgen	None	First approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture (brand name Prolia). Under the brand name XGEVA, denosumab is also approved for prevention of skeletal-related events in patients with bone metastases from solid tumors; treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; and hypercalcemia of malignancy	None	2010	12/19/2008	06/01/2010	Denosumab	Bone-related diseases. As Xgeva: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors; Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy; treatment for adult multiple myeloma patients to prevent skeletal-related events (EU). As Prolia: Treatment of postmenopausal women with osteoporosis at high risk for fracture, Treatment to increase bone mass in men with osteoporosis at high risk for fracture, Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer); treatment for glucocorticoid-induced osteoporosis in men and women with high fracture risk	Thousand Oaks, California, United States	United States of America	North America	https://www.amgen.com/
Approved	YABS0019	09/19/2018	Erenumab	AMG 334	Aimovig	mAb human	Naked monospecific	Full length Ab	None	CGRP receptor	IgG2	lambda	None	None	None	GPCR target. Ab generation: XenoMouse were immunized with purified soluble CGRP receptor protein as the antigen. Soluble CGRP receptor polypeptides containing the N-terminal extracellular domains (ECDs) of human CRLR (amino acids 1–138 of GenBank accession no. AAA62158) and human RAMP1 (amino acids 1 to 117 of GenBank accession no. CAA04472) were generated by transiently cotransfecting 293 6E cells. Hybridomas are generated from a pool of mice with the highest sera titer using a standard protocol (Kearney et al., 1979) and AMG 334 is identified through screening assays including binding competition, functional blocking, and receptor selectivity against the human CGRP receptor (Journal of Pharmacology and Experimental Therapeutics January 2016, 356 (1) 223-231; DOI: https://doi.org/10.1124/jpet.115.227793)	Transgenic mouse (Xenomouse)	None	Approved EU, US, Japan, Australia	Active	03/15/2012	08/15/2013	07/15/2015	Migraine, Vasomotor Symptoms; Hot Flashes	Neurological disorders	Amgen	None	Approved in US on May 17, 2018. Sep 2016: Phase 3 migraine study end point met. Two Phase 3 studies in migraine started in July 2015. Positive Phase 2 study results reported in May 2015. Phase 2 studies recruiting as of Feb 2014	None	2018	05/17/2017	05/17/2018	Erenumab, erenumab-aooe	Preventive treatment of migraine in adults	Thousand Oaks, California, United States	United States of America	North America	https://www.amgen.com/
Approved	YABS0020	12/15/2019	Romosozumab	AMG 785, CDP-7851	EVENTIY	mAb humanized	Naked monospecific	Full length Ab	None	Sclerostin	IgG2	kappa	None	None	None	None	None	None	Approved EU, US, Japan, Australia	Active	11/01/2006	—	03/15/2012	Postmenopausal Osteoporosis, Fracture Healing	Skeletal disorders	UCB	Amgen	FY 2019 FDA report to congress: 1st cycle 11.8 months; sponsor 11.9 months; 2nd cycle 9.0 months First approved in Japan on January 8, 2019, approved in EU in Dec 2019. Dec 2019: Approved in EU. October 18, 2019: UCB and Amgen announced that following a re-examination procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion recommending Marketing Authorization for EVENITY® (romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke. The CHMP’s recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use throughout the European Union. A European Commission decision is expected by year-end 2019. July 2019: UCB appealed EMA's negative opinion. The European Medicines Agency recommended the refusal of the marketing authorisation for Evenity, a medicine intended for the treatment of osteoporosis. The Agency issued its opinion on 27 June 2019. The company that applied for authorisation, UCB Pharma S.A., may ask for re-examination of the opinion within 15 days of receiving the opinion. The Agency was concerned because the results suggested that patients given Evenity had an increased risk of serious effects on the heart or circulatory system, such as heart attacks or strokes. In addition, when all the data were looked at together, there were more deaths in patients aged over 75 years given the medicine. As it was unclear why the medicine appeared to increase the risk of heart and circulatory problems, and there was no obvious group of patients in whom the risk of these was lower, measures to reduce the risk could not readily be put in place. Approved in the US on April 9, 2019. First approved in Japan on January 8, 2019. An FDA advisory committee voted 18-1 in favor of Amgen's Evenity, or romosozumab, as a treatment for postmenopausal women with osteoporosis who are deemed to be at high risk for bone fractures. AMGN along with European partner UCB announced that the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) will review its biologics license application (BLA) for Evenity (romosozumab) on Jan 16, 2019. J uly 12, 2018: Amgen and UCB resubmitted BLA to FDA. July 2017: A complete response letter was issued by the FDA to Amgen and UCB regarding its biologics license application for Evenity, or romosozumab, intended to treat osteoporosis. The letter requires resubmission of the application to include efficacy and safety data from a Phase III trial assessing Evenity in men with osteoporosis in addition to efficacy data from a late-stage study of postmenopausal women with osteoporosis included in the original submission. PDUFA date: July 19, 2017. (Rolling?) BLA submission announced July 21, 2016. Primary endpoint met in Phase 3 STRUCTURE study. Partnership with Astellas for marketing in Japan. The romosozumab IND (100391) was opened in November 2006 (as per BLA document).	None	2019	07/19/2016	04/09/2019	Romosozumab, romosozumab-aqqg	Treatment of osteoporosis in postmenopausal women at high risk for fracture	Allée de la Recherche, 60 1070 Brussels Belgium	Belgium	Europe	https://www.ucb.com/contact