Bristol Myers Squibb announced the commercial US launch of ozanimod (Zeposia) for the treatment of relapsing forms of multiple sclerosis.
Ozanimod (Zeposia), Bristol Myers Squibb’s oral treatment for relapsing forms of multiple sclerosis (RMS), is now commercially available in the United States, the company announced in a press release.
Ozanimod 0.92 mg, which was approved by the FDA on March 25, 2020, is indicated for the treatment of RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. The once-daily oral medication is the first S1P receptor modulator with no genetic test or first dose observed at initiation, according to Bristol Myers Squibb.
An up-titration scheme should be used to reach the maintenance dosage of ozanimod, as a transient decrease in heart rate and atrioventrical conduction delays may occur, Bristol Myers Squibb said.
“We are pleased to now bring Zeposia, an important new once daily treatment option, to RMS patients,” Tina Deignan, vice president and US head of immunology at Bristol Myers Squibb, said in a statement. “Zeposia is the first and only S1P that requires no first dose observation, which may minimize the number of interactions RMS patients need to have with health care practitioners prior to initiating therapy during this unprecedented time of social distancing.”
The approval of oral ozanimod was based on data from 2 phase 3 trials: SUNBEAM and RADIANCE. The SUNBEAM study evaluated the safety and efficacy of ozanimod versus interferon beta-1a (Avonex) in RMS for at least a 12-month treatment period in 1346 patients. The primary end point was annualized relapse rates (ARR) during the study.
The RADIANCE study included 1320 individuals with RMS who received either ozanimod or weekly intramuscular interferon beta-1a over a 24-month period. The primary end point was ARR over 24 months.
The drug is contraindicated in patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III/IV heart failure; patients who have a presented of Mobitz type II second or third-degree atrioventricular block, sick sinus syndrome, or sino-atrial, unless the patient has a functioning pacemaker; patients with severe untreated sleep apnea; and patients taking a monoamine oxidase inhibitor.
The ZEPOSIA 360 Support program will help facilitate access to ozanimod for appropriate patients with MS, including a copay of as little as $0 for eligible patients, assistance with financial support, reimbursement for some initial out-of-pocket medical costs, and a program that may help certain patients with commercial insurance receive free medication while they are waiting for insurance approvals.
Ozanimod is also in development for additional immuno-inflammatory indications, including ulcerative colitis and Crohn disease, according to the press release.
1. Bristol Myers Squibb Announces Commercial Launch and Availability of Zeposia (ozanimod), a New Oral Treatment for Relapsing Forms of Multiple Sclerosis. News Release. Bristol Myers Squibb; June 1, 2020. Accessed June 3, 2020. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-announces-commercial-launch-and-availabil