Novartis AG NVS announced that the FDA accepted its Biologics License Application (BLA) for its investigational medicine, crizanlizumab (SEG101), to prevent pain crises (also called vaso-occlusive crises, or VOCs) in patients with sickle cell disease. The agency also granted Priority Review to the same.
Notably, Priority Review designation is granted to drugs that have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. The designation is intended to shorten the FDA review period to six months from the standard ten months.
If approved, crizanlizumab will be the first monoclonal antibody, targeting the P-selectin mediated multi-cellular adhesion in SCD.
Novartis submitted the application for crizanlizumab for the prevention of vaso-occlusive crises (VOCs) in patients with SCD and the candidate was granted Breakthrough Therapy designation in December 2018. The FDA submission was supported by phase II results from the SUSTAIN study, which showed that crizanlizumab (5 mg/kg) reduced the median annual rate of VOCs leading to health care visits by 45.3% compared with placebo in patients with or without hydroxyurea. The study showed clinically significant reductions in the frequency of VOCs among patients, regardless of SCD genotype or hydroxyurea use. Vaso-occlusive crises are unpredictable and extremely painful events that can lead to serious life-threatening complications or death.
Shares of the company have increased 4.1% year to date against the industry’s decline of 1.5%.
We remind investors that Global Blood Therapeutics GBT is also evaluating a pipeline candidate, voxelotor, in a phase III study in adult and adolescent patients with SCD. Also, Vertex Pharmaceuticals Incorporated VRTX and its partner CRISPR Therapeutics AG CRSP are developing CTX001 for the treatment of SCD.
Novartis currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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