Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 146 |
| INN | Crizanlizumab |
| Status | Approved |
| Drug code(s) | SEG101, SelG1 |
| Brand name | Adakveo |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | P-selectin |
| Indications of clinical studies | COVID-19, Phase 1 in healthy subjects, vasoocclusion in sickle cell disease |
| Primary therapeutic area | Cardiovascular / hemostasis disorders |
| Most advanced stage of development (global) | Approved US, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 01, 2011 |
| Start of Phase 2 | August 15, 2013 |
| Start of Phase 3 | December 15, 2016 |
| Date BLA/NDA submitted to FDA | May 16, 2019 |
| Year of first approval (global) | 2019 |
| Date of first US approval | November 15, 2019 |
| INN, US product name | Crizanlizumab, crizanlizumab-tmca |
| US or EU approved indications | Indicated to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients age 16 years and older. |
| Company | Novartis Pharmaceuticals |
| Licensee/Partner | None |
| Comments about company or candidate | Feb 2024: Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA. Aug 2023: EC withdraws marketing authorization. The decision was based on a review of crizanlizumab initiated by the EC following the results of the phase III study, STAND (NCT03814746). The STAND study did not demonstrate a statistically significant difference between crizanlizumab 5mg/kg or crizanlizumab 7.5mg/kg and placebo in annualized rates of vaso-occlusive crises leading to a healthcare visit over the first-year post randomization. May 2023: EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo. EMA’s human medicines committee (CHMP) has recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing painful crises (called vaso-occlusive crises) in patients aged 16 years and older with sickle cell disease. This follows a review by the CHMP, which concluded that the benefits of the medicine did not outweigh its risks. Approved by EU on Oct 28, 2020; Orphan market exclusivity for "Treatment of sickle cell disease" (based on designation EU/3/12/1034) started on 29 Oct 2020 July 16 2019 announcement: BLA has priority review. Jan 2019: The FDA granted breakthrough therapy status to Novartis' SEG101, or crizanlizumab, a monthly infusion being developed as a treatment for patients with vaso-occlusive crises in sickle cell disease. NCT03474965 Phase 2 study started in Oct 2018. July 2018: Regulatory filing planned for 2019. Listed as Phase 3 in Novartis pipeline (accessed online July 2018). Listed as Phase 3 in Novartis 2016 annual report. Dec 2016: Results from the Phase II SUSTAIN study show that SEG101 (crizanlizumab, formerly SelG1), an anti-P-selectin antibody, reduced the median annual rate of sickle cell-related pain crises (SCPC) by 45.3% compared to placebo (1.63 vs 2.98, p=0.010) in patients with or without hydroxyurea therapy. Novartis acquired Selexys Pharmaceuticals Corporation in Nov 2016, NCT01895361 Phase 2 in sickle cell disease with pain crisis. Selexys has been granted Orphan Drug Designation in both the U.S. and Europe for SelG1 in the treatment of sickle cell-related pain crises. |
| Full address of company | Basel, Switzerland Europe Switzerland https://www.novartis.com/contacts |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |