Novartis Receives FDA Nod for Adakveo in Sickle Cell Disease

Novartis 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 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 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 industry’s growth of 4.7%.

Concurrently, Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for multiple sclerosis drug, Mayzent (siponimod). The CHMP recommended approval of the drug for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity.

The CHMP opinion is based on the phase III EXPAND study, the largest, randomized, clinical study in a broad SPMS patient population (EDSS score 3.0 to 6.5 at baseline), which showed that Mayzent significantly reduced the risk of disease progression, including physical disability and cognitive decline.

The drug is already approved in the United States for the treatment of relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome (CIS†), relapsing remitting disease and active secondary progressive disease, in adults.

Zacks Rank & A Stock to Consider

Novartis currently carries a Zacks Rank #3 (Hold).

A better-ranked large-cap drug stock is Bristol-Myers Squibb Company BMY, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Bristol-Myers’ earnings estimates increased to $4.33 from $4.28 for 2019 over the past 30 days.

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