FDA approves Zeposia for relapsing forms of multiple sclerosis in adults
The U.S. Food and Drug Administration (FDA) has approved Zeposia (ozanimod) oral medication to treat adults with relapsing forms of multiple sclerosis (MS). This includes relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS).
ZEPOSIA is an oral capsule to be taken once daily.It 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.
Multiple sclerosis (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. This "signal breakdown" can lead to symptoms and relapses.6,8
"With the Food and Drug Administration 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,"said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. "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."
An sphingosine-1-phosphate (S1P) receptor modulator, Zeposia is the first in this class allowing people with relapsing MS to "initiate" treatment — via a recommended up-titration scheme before reaching a maintenance dose once-a-day treatment (0.92 mg) — without requiring a genetic test or a first-dose observation period, BMS said in its release.
In clinical trials, ZEPOSIA demonstrated efficacy on a key clinical marker of disease activity – annualized relapse rate (ARR) – as compared to AVONEX ® (interferon beta-1a).
The trials compared the safety and effectiveness of two doses of ozanimod capsules (0.5 mg and 1 mg), given daily, to that of weekly intramuscular injections of Avonex for up to two years in people with RRMS or active SPMS.
The trial showed that both doses led to significantly greater reductions in annualized relapse rates — the number of relapses per year — and brain lesions in these patients, compared with Avonex.
"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," said Samit Hirawat, MD, the company's chief medical officer.
The use of Zeposia can also lead to significantly lesser brain atrophy (shrinkage), and to clinically meaningful improvements in patients' cognitive processing speed.
A market authorization request has also been submitted to the European Medicines Agency, seeking Zeposia's approval as a treatment for RRMS. This application is under review, with a decision is expected in the first half of this year.
Bristol Myers Squibb has made the decision to delay commercialization of ZEPOSIA due to prevailing Covid 19 pandemic.