Bristol Myers Scores FDA Approval for Celgene’s MS Drug Ozanimod
FDA approved the MS drug ozanimod after initially rejecting the drug prior to the Bristol Myers-Celgene merger, but challenges are not over for release of the drug.
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By The FDA finally approved Zeposia (ozanimod), a multiple sclerosis (MS) drug developed by Celgene, according to a recent announcement from the Bristol-Myers Squibb Company.
- Bristol-Myers acquired Celgene in a $74 billion merger deal last year. The company had its eyes on several of Celgene’s drugs in development, including ozanimod, which will carry the brand name Zeposia, according to Bristol Myers announcement.
“With the FDA approval of Zeposia, appropriate patients with relapsing forms of multiple sclerosis will have another oral treatment option with meaningful efficacy to help address the disease’s hallmark relapses and brain lesions,” Samit Hirawat, MD, chief medical officer at Bristol Myers Squibb, said in the announcement
“Zeposia has substantial clinical potential, and we are well positioned with our heritage in transformational science to ensure this innovative compound ultimately benefits as many patients as possible.”
Multiple sclerosis is a disease where 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, the announcement stated. Occasionally, the signal breakdown may lead to relapses.
Zeposia will address relapsing forms of MS including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Zeposia is the only approved sphingosine-1-phosphate (S1P) receptor modulator that provides a treatment for patients with no genetic test and no label-based first-dose observation required for patients, Bristol Myers added.
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FDA approved the MS drug ozanimod after originally rejecting the drug, which solidifies the Bristol Myers-Celgene merger.
The administration based its approval on data from the largest pivotal, head-to-head RMS study, the randomized, active-controlled Phase III Sunbeam and Radiance Part B clinical trials of over 2,600 adults.
But before receiving FDA approval, ozanimod faced its own set of challenges.
In February 2018, Celgene announced that it received a refusal to file letter from FDA regarding ozanimod. The agency determined that the nonclinical and clinical pharmacology sections in the non-disclosure agreement (NDA) were “insufficient” to permit a complete review.
A year later, in January 2019, Bristol-Myers Squibb acquired Celgene in a $74 billion deal. Celgene shareholders would receive one BMS share and $50 cash for each Celgene share they own. The value of the deal is nearly $95 billion, making it the largest healthcare deal on record.
Five months later, in June, Celgene announced that FDA accepted for review the New Drug Application for ozanimod. The European Medicines Agency (EMA) also accepted the Marketing Authorization Application for the drug in the European Union as well.
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“The U.S. Food and Drug Administration and European Medicines Agency acceptances of our applications represent a crucial step forward in our efforts to bring ozanimod to people with multiple sclerosis,” Jay Backstrom, MD, chief medical officer for Celgene, said in the announcement. “We believe that ozanimod has the potential to be an important option early in the treatment of relapsing forms of MS and a best-in-class S1P receptor modulator.”
Ozanimod was one of the drugs that needed support for the Bristol Myers- Celgene merger to gain acceptance among stakeholders. This approval further solidifies the deal as beneficial.
The Bristol Myers announcement stressed that ozanimod may cause a decrease in heart rate and atrioventricular (AV) conduction delays may occur, so maintaining dosage vital. The drug is also associated with various precautions including liver injury, fetal risk, increased blood pressure, respiratory effects, bradyarrhythmia and atrioventricular conduction delays, among other conditions.
Before patients are cleared to take ozanimod, they are required to take an assessment including blood count, an ECG to determine preexisting conditions, a liver function test, and current or prior medications.
Bruce Cree, MD, PhD, MAS, professor of clinical neurology at the University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director at UCSF MS Center explained that a treatment for relapsing forms of multiple sclerosis is critical to address this “devastating neurological disease.”
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“Multiple sclerosis is an unpredictable and often disabling disease that affects nearly one million people in the United States. Ongoing treatment with disease-modifying therapy can reduce the number of disease attacks,” said Bruce Bebo, executive vice president of research at the National Multiple Sclerosis Society.
“Each person can respond differently to these medications, which is why having treatment options is so important. We are pleased that there will now be another effective treatment option for people with MS.”
Most recently, Bristol Myers made the decision to suspend commercialization of Zeposia during the COVID-19 outbreak based on the best interest of patients, customers, and employees. The company emphasized that it will continue to monitor the situation and partner with the community to inform the public of launch timing.
