Bristol Myers Squibb’s Ozanimod Wins FDA Approval for Relapsing Multiple Sclerosis

Bristol Myers Squibb’s ozanimod won approval from the U.S. Food and Drug Administration (FDA) as a new treatment for a type of multiple sclerosis. This is the first approval for the company since it completed its merger with Celgene in November 2019 and it has the potential to be a blockbuster.

This morning, BMS announced the FDA approved ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The newly-approved drug will be marketed under the brand name Zeposia. BMS said Zeposia is the only approved sphingosine-1-phosphate (S1P) receptor modulator that offers RMS patients an initiation with no genetic test and no label-based first-dose observation required for patients.

Approval of Zeposia is based on data from the Phase III SUNBEAM and RADIANCE trials. In the trials, Zeposia was compared to Biogen’s Avonex (interferon beta-1a). BMS said during the trials, Zeposia “delivered powerful efficacy” as measured by annualized relapse rate (ARR), as well as on the number and size of brain lesions. In the trials, Zeposia reduced ARR by 48% through one year and 38% over two years. With brain lesions, at one year, Zeposia reduced the number of T1-weighted gadolinium-enhanced (GdE) brain lesions by 63%, which was greater than the reduction from Avonex. The medication also reduced new or enlarging T2 lesions by 48%.

Samit Hirawat, chief medical officer for Bristol Myers Squibb, said the approval of Zeposia provides a new treatment option to address “the disease’s hallmark relapses and brain lesions.” Hirawat said BMS is well-positioned to ensure that the drug benefits as many patients as possible. Zeposia will enter a market that includes Avonex, Genentech’s Ocrevus and EMD Serona’s Rebif.

For BMS and Celgene, the approval has not been easy. In 2018, when the drug was under the umbrella of Celgene, the company was stunned when the FDA issued a Refusal to File letter regarding some insufficient data. The company refiled its New Drug Application after completing some non-clinical bridging studies and was ultimately awarded the approval. Celgene gained ozanimod in the 2015 $7.2 billion acquisition of Receptos Inc.

Although Zeposia has now been approved in the United States, BMS said it was delaying commercialization due to the “unprecedented COVID-19 pandemic.” Bristol Myers Squibb will continue to monitor the environment and will partner with the neurology community to inform launch timing. The company is also expecting a decision from the European Medicines Agency later this year. A Marketing Authorization Application for Zeposia is under review for the European Union.

The cause of multiple sclerosis (MS) is not known and there is no cure for the debilitating disease. It is estimated that about 2.3 million people globally live with the disease, with hundreds of thousands more who remain undiagnosed. MS is a disease in which the immune system attacks the protective myelin sheath that covers the nerves, creating damaging lesions that make it harder for signals to travel between each nerve cell. RMS is characterized by clearly defined attacks of worsening neurologic function.

BMS is also studying Zeposia as a potential treatment for additional immune-inflammatory indications, including ulcerative colitis and Crohn’s disease.