The Food and Drug Administration has approved a Bristol-Myers Squibb drug for multiple sclerosis that was one of the showcase pipeline candidates in BMS’ $74 billion acquisition of Celgene last year.
BMS said Thursday that the FDA had approved Zeposia (ozanimod) for relapsing MS in adults, including those with clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The New York-based drugmaker said it marked the first new FDA-approved drug since it acquired Celgene.
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Shares of BMS were up about 6% in afternoon trading on the New York Stock Exchange Thursday.
“Treatment for relapsing forms of multiple sclerosis is critical to address this devastating neurological disease,” University of California San Francisco professor of neurology Dr. Bruce Cree said in a statement for the company.
The drug’s approval is based on data from two Phase III trials, SUNBEAM and RADIANCE, which compared Zeposia against Biogen’s Avonex (interferon beta-1a) in more than 2,600 patients. Results of the study showed that Zeposia produced a relative 48% reduction in annualized relapse rate through one year compared with Avonex and a 38% reduction through two years. Use of the drug also resulted in 63% fewer T1-weighted gadolinium-enhanced brain lesions, while the number of new or enlarging T2 lesions saw a relative reduction of 48%. There was no statistically significant difference in disease progression between patients receiving Zeposia and those receiving Avonex in terms of disability progression at three or six months.
Despite the fanfare, the company said it would delay the drug’s rollout because due to the healthcare system’s focus on the Covid-19 pandemic, with a growing number of hospitals finding themselves overwhelmed with patients suffering from the disease. Several other companies, including Pfizer, Eli Lilly and BMS itself, have announced plans to pause certain clinical trial operations in order to help health systems cope. Other companies, like bluebird bio and Intercept Pharmaceuticals, have experienced delays in their regulatory dealings with the FDA due to the pandemic.
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