FDA Approves Ozanimod for Relapsing Multiple Sclerosis

Officials with the FDA have granted approval to ozanimod (Zeposia, Bristol Myers Squibb) for the treatment of relapsing multiple sclerosis (RMS), according to a press release.

The approval includes indicated uses for clinically isolated syndrome, relapsing-remitting disease, and active secondary disease.

Ozanimod is the only approved spingosine-1-phosphate (S1P) receptor modulator that offers patients with RMS an initiation with no genetic test and no label-based first-dose observation required. It is an oral medication taken once daily. An up-titration scheme should be used to reach maintenance dosage of ozanimod, as a transient decrease in heart rate and atrioventrical conduction delays may occur, according to Bristol Myers Squibb.

The approval was supported by data from the phase 3 SUNBEAM, which evaluated the safety and efficacy of ozanimod versus interferon beta-1a (Avonex) in RMS, and the RADIANCE ,which evaluated the safety and efficacy of ozanimod in RMS, Part B clinical trials.

In the SUNBEAM trial, oral ozanimod (0.92 mg, equivalent to 1 mg) was evaluated against weekly intramuscular interferon beta-1a for at least a 12-month treatment period in 1346 patients. The primary endpoint was annualized relapse rates (ARR) during the study.

The RADIANCE study included 1320 individuals with RMS who received either ozanimod (0.92 mg) or weekly intramuscular interferon beta-1a over a 24-month period. The primary endpoint was ARR over 24 months.

Key findings across both trials showed:

• Ozanimod demonstrated a relative reduction in ARR versus interferon beta-1a of 48% through 1 year and 38% at 2 years (absolute ARR of 0.18 versus 0.35 and 0.17 versus 0.28, respectively).

• At 1 year, treatment with ozanimod reduced the number of T1-weighted gadolinium-enhanced (GdE) brain lesions more than interferon beta-1a (0.16 versus 0.43), a relative reduction of 63%, and reduced the number of new or enlarging T2 lesions (1.47 versus 2.84), a relative reduction of 48%.

• At 2 years, treatment with ozanimod reduced the number of T1-weighted GdE brain lesions more than interferon beta-1a (0.18 versus 0.37), a relative reduction of 53%. Ozanimod also reduced the number of new or enlarging T2 lesions versus interferon beta-1a (1.84 versus 3.18), a relative reduction of 42%.

According to the data, there was no statistically significant difference in the 3-month and 6-month confirmed disability progression between ozanimod- and interferon beta-1a-treated patients over 2 years.

Overall, ozanimod demonstrated acceptable safety and tolerability in both trials. 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.

“Multiple sclerosis is an unpredictable and often disabling disease that affects nearly 1 million people in the United States,” Bruce Bebo, executive vice president of research, National Multiple Sclerosis Society, said in a statement. “Ongoing treatment with disease-modifying therapy can reduce the number of disease attack. 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.”

References:

1. US Food and Drug Administration Approves Bristol Myers Squibb’s Zeposia (ozanimod), a New Oral Treatment for Relapsing Forms of Multiple Sclerosis [news release]. Bristol Myers Squibb’s website. https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-bristol-myers-squibbs. Accessed March 27, 2020.