Novartis Receives FDA Nod For Adakveo In Sickle Cell Disease
Zacks Investment Research | Nov 17, 2019 09:36PM ET
Novartis (NYSE:NVS) announced that the FDA has approved Adakveo (crizanlizumab) to reduce the frequency of vaso-occlusive crises (VOCs) or pain crises in adult and pediatric patients aged 16 years or above with sickle cell disease (SCD).
The FDA’s approval was based on the results of the 52-week, randomized, placebo-controlled SUSTAIN study. The study results showed that Adakveo (previously known as SEG101) reduced the annual rate of sickle cell pain crises by 45% compared to placebo (1.63 vs 2.98) and the annual rate of days hospitalized (4 vs 6.87).
By binding to P-selectin on the surface of the activated endothelium and platelets, Adakveo blocks interactions between endothelial cells, platelets, red blood cells and leukocytes
The approval comes approximately two months ahead of FDA’s priority review action date. Approximately 100,000 people in the United States, most of whom are of African descent, suffer from SCD.
We remind investors that Global Blood Therapeutics (NASDAQ:GBT) is also evaluating voxelotor in patients with SCD. The FDA accepted for filing the company’s New Drug Application (NDA) seeking accelerated approval of the candidate for the treatment of SCD. The FDA granted Priority Review and assigned a Prescription Drug User Fee Act target action date of Feb 26, 2020. bluebird bio (NASDAQ:BLUE) is also evaluating LentiGlobin in SCD.
Approval of new drugs bodes well for Novartis. The company has a strong oncology portfolio along with other key drugs, which continue to boost sales. However, it is facing the loss of patent protection for some of these drugs.
Shares of the company have gained 5% year to date compared with the Original post
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