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Bristol Myers' (BMY) Application for UC Drug Validated by EMA

·3 min read

Bristol Myers Squibb BMY announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

Zeposia is an oral, sphingosine-1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5.

The MAA was based on positive results from the phase III True North study, which is evaluating Zeposia as an induction and maintenance therapy in adults with moderately to severely active UC. True North met both primary endpoints, demonstrating highly statistically significant and clinically meaningful results for clinical remission compared to placebo in induction at week 10 and in maintenance at week 52. The overall safety observed in the study was consistent with the known safety profile for Zeposia in approved labeling.

The validation of the application confirms the completion of the submission and the beginning of the EMA’s centralized review process.

UC is a chronic inflammatory bowel disease (IBD). It is characterized by an abnormal, prolonged immune response that creates long-lasting inflammation and ulcers (sores) in the mucosa (lining) of the large intestine (colon) or rectum.

We note that Zeposia is already approved in the United States for the treatment of adults with relapsing forms of multiple sclerosis (RMS). The European Commission also approved Zeposia for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) in May 2020.

Meanwhile, Bristol Myers continues to evaluate Zeposia in an open-label extension trial, which is ongoing and designed to assess the longer-term profile of the drug for the treatment of moderately to severely active UC. Zeposia is also being evaluated for the treatment of moderately to severely active Crohn’s disease in the ongoing phase III YELLOWSTONE clinical trial program.

The successful development of Zeposia will boost the growth potential of the drug, which was added to Bristol Myers’ portfolio following the Celgene acquisition.

Shares of Bristol Myers have decreased 1.2% against the industry’s growth of 7.6%.

Drugs approved for UC include Pfizer’s PFE Xeljanz and Takeda Pharmaceutical Co.’s TAK Entyvio, among others.

Zacks Rank & A Stock to Consider

Bristol Myers currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Halozyme Therapeutics, Inc. HALO, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Halozyme’s earnings estimates have grown 22 cents for 2020 and 26 cents for 2021 in the past 60 days.

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