Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 128 |
| INN | Lebrikizumab |
| Status | Approved |
| Drug code(s) | RG3637, TNX-650, PRO301444, MILR1444A |
| Brand name | Ebglyss |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IL-13 |
| Indications of clinical studies | Atopic dermatitis, Idiopathic pulmonary fibrosis, Asthma, Hodgkin's Lymphoma |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia, Canada, Switzerland |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2005 |
| Start of Phase 2 | December 15, 2008 |
| Start of Phase 3 | April 15, 2012 |
| Date BLA/NDA submitted to FDA | September 28, 2024 |
| Year of first approval (global) | 2023 |
| Date of first US approval | September 13, 2024 |
| INN, US product name | Lebrikizumab |
| US or EU approved indications | Moderate to severe atopic dermatitis |
| Company | Genentech |
| Licensee/Partner | Almirall, Lilly, Roche, Chugai |
| Comments about company or candidate | Apr 2024: Resubmission of lebrikizumab for adult and adolescent patients with moderate-to-severe atopic dermatitis in the U.S. with expected regulatory action in the second half of 2024. https://investor.lilly.com/news-releases/news-release-details/lilly-reports-first-quarter-2024-financial-results-and-raises Approved by the EC on November 16, 2023 Oct. 2, 2023: Eli Lilly and Company announced that the U.S. Food and Drug Administration has issued a complete response letter for the lebrikizumab biologic license application for the treatment of moderate-to-severe atopic dermatitis (eczema). The letter cited findings that arose during a multi-sponsor inspection of a third-party, contract manufacturing organization that included the monoclonal antibody drug substance for Lilly's lebrikizumab. Sep 15 2023: CHMP issues a positive opinion; approval expected in 67 days. Authorization date = 16 November 2023 Q2 2023: Regulatory actions expected in US and EU in 2023 (https://investor.lilly.com/static-files/66ea0c52-8756-413f-b898-f69c78b191ec) Almirall H1 2022 presentation: On track to submit for regulatory approval in H2 2022 a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) based on data from the phase III clinical trial program. (https://www.almirall.com/documents/portlet_file_entry/4257831/Financial+Results_Business+Update_H1+2022_Final.pdf/830d58c1-85c2-b29c-b719-2bdb54b07f98) BLA 761306 submitted Sep 28, 2022; rebusmission Mar 14, 2024 (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761306Orig1s000MultidisciplineR.pdf) As of Aug 2022, 4 Phase 3 studies are pending or recruiting; primary completion dates are Aug 2023-May 2024. NCT04250350 and NCT04250337 Phase 3 studies in atopic dermatitis completed. On January 10, 2020 Eli Lilly and Company and Dermira, Inc. announced a definitive agreement for Lilly to acquire Dermira. On December 10, 2019 Dermira, Inc. announced that the FDA granted Fast Track designation for lebrikizumab. NCT04178967 Phase 3 ADvocate2 study started in Nov 2019. Phase 3 study Dec 2019: The U.S. Food and Drug Administration (FDA) granted lebrikizumab Fast Track designation in AD. Oct 2019: Dermira announced dosing of the first patient in a Phase III study (NCT04146363, ADvocate1) evaluating the safety and efficacy of lebrikizumab in adult and adolescent patients ages 12 and older with moderate-to-severe atopic dermatitis, the most common form of eczema. June 2019: Almirall has exercised its option to license rights to develop and commercialize lebrikizumab for the treatment of atopic dermatitis and certain other indications in Europe. Dermira plans to initiate a Phase 3 clinical development program for lebrikizumab by the end of 2019. February 12, 2019: Almirall, S.A. and Dermira, Inc. announced that the companies have entered into an option and license agreement under which Almirall has acquired an option to exclusively license rights to develop and commercialize lebrikizumab for the treatment of atopic dermatitis and certain other indications in Europe. In exchange, Dermira will receive an upfront option fee of $30 million. If Almirall exercises its option to obtain the license following the results of the ongoing Phase 2b study, Dermira will receive a $50 million option exercise fee and will be eligible to receive additional development, regulatory and sales milestone payments, as well as double-digit royalties Q1 2018: Chugai discontinuted development for idiopathic pulmonary fibrosis considering the results of the Phase 2 RIFF study. Aug. 08, 2017: Dermira, Inc. announced that it has entered into a licensing agreement with F. Hoffmann-La Roche Ltd and Genentech, Inc., a member of the Roche Group (together Roche). Pursuant to the agreement, Dermira will obtain exclusive, worldwide rights to develop and commercialize lebrikizumab, a monoclonal antibody targeting interleukin 13 (IL-13), for atopic dermatitis and all other indications, except Roche will retain certain rights, including exclusive rights to develop and promote lebrikizumab for interstitial lung diseases, such as idiopathic pulmonary fibrosis. Dermira plans to initiate a Phase 2b dose-ranging study assessing lebrikizumab in adult patients with moderate-to-severe atopic dermatitis in the first quarter of 2018. Listed as Phase 2 for atopic dermatitis in pipeline dated July 21, 2016. Q1 2017: Removed from pipeline for COPD. In July 2016, the company announced the discontinion of the drug candidate for severe asthma. Feb 2016: Of 2 identical Phase 3 studies, LAVOLTA I met its primary endpoint, showing a significant reduction in the rate of asthma exacerbations in people with higher levels of serum periostin or blood eosinophils, both biomarkers of airway inflammation. In addition, this study demonstrated a significant improvement in lung function as measured by forced expiratory volume in one second (FEV1). The observed effect in the primary and secondary endpoints, however, was less than seen in the lebrikizumab phase II trials. In contrast, the exacerbation reduction results observed in LAVOLTA II did not meet statistical significance. No new safety signals were observed in either study. Phase 2 in IPF due to start in September 2013; Roche expects to have a data publication for the Phase IIb LUTE study of Lebrikizumab in 2014 |
| Full address of company | South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us |
Hinge-stabilized
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |