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Bristol Myers follows Zeposia launch with positive data from key study.

Adding Bristol Myers Squibb's drug Zeposia to standard treatment helped relieve ulcerative colitis symptoms in more patients than did placebo, the company announced Tuesday.

Already approved to treat multiple sclerosis, Zeposia could become the first drug in its class, and one of several new oral pills, to be used for the inflammatory digestive disease. Pfizer's Xeljanz has been approved for ulcerative colitis since 2018, while AbbVie and Gilead are also developing existing drugs for the condition.

Zeposia received Food and Drug Administration approval just as the scope of the coronavirus pandemic was becoming clear in the U.S. and as health care providers were worried about becoming overwhelmed with cases.

Now, with some physicians' offices beginning to reopen, the New York-based drugmaker decided to begin offering the drug commercially. Zeposia will have an annual list price of $86,000, a company spokesperson told BioPharma Dive, putting it in line with several existing therapies for the disease.

In multiple sclerosis, Zeposia is the third drug in its class, known as S1P receptor modulators, to win approval, following Novartis' Gilenya and Mayzent. Neither of those drugs is prescribed beyond multiple sclerosis, however, so Zeposia's success in ulcerative colitis could mean it is used more broadly.

Bristol Myers did not disclose detailed data from its ulcerative colitis study, dubbed True North. The company said Zeposia met the trial's primary goal of demonstrating significantly higher remission rates than placebo over an initial 10-week phase and a subsequent year-long maintenance period. Full results will be presented at a medical meeting.

In Phase 2 testing, Zeposia at the dose studied in True North led to disease remission in 16% of patients, which, while greater than a placebo arm doesn't look different than the rates achieved by Xeljanz or injected biologic drugs like AbbVie's Humira, Johnson & Johnson's Stelara and Takeda's Entyvio. Cross-trial comparisons are difficult, however, and don't necessarily present an accurate picture of drugs' relative effectiveness.

Among experimental oral drugs, Gilead and Galapagos' filgotinib achieved an 11% remission rate among patients who hadn't received a biologic drug and 7% among those who had. However, another S1P drug being tested in ulcerative colitis, Arena Pharmaceuticals' etrasimod, achieved a 33% remission rate in a Phase 2 trial.

Arena shares rose by as much as 16% in Tuesday morning trading.

Author:Jonathan Gardner

Published: June 2, 2020

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