The FDA has set a PDUFA date of March 25, 2020.
The FDA has accepted the new drug application for ozanimod for the treatment of relapsing forms of multiple sclerosis. The Prescription Drug User Fee Act action date has been set for March 25, 2020, according to Celgene.
The application is backed by data from 2 phase 3 multicenter, randomized, double-blind, double-dummy, active-controlled trials, SUNBEAM (NCT02294058) and RADIANCE (NCT01628393).
“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 Backstorm, MD, chief medical officer, Celgene, said in a statement.1 “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.”
SUNBEAM, a pivotal phase 3 trial, evaluated the efficacy, safety, and tolerability of 2 doses of oral ozanimod (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI, respectively) against weekly intramuscular interferon ß-1a (Avonex) for at least a 12-month treatment period in 1346 participants with relapsing multiple sclerosis across 152 sites in 20 countries.
The primary endpoint was the annualized relapse rate during the treatment period, while secondary endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 12 months; the number of gadolinium-enhancing brain MRI lesions at 12 months; and the percent change in whole brain volume.
In February 2017, Celgene announced positive topline data which revealed that both of the ozanimod treatment arms demonstrated statistically significant and clinically meaningful improvements compared with interferon ß-1a in annualized relapse rate and a number of secondary endpoints.2
In the RADIANCE trial, ozanimod was evaluated in 1320 participants with relapsing multiple sclerosis enrolled across 150 sites in 21 countries. Similar to the SUNBEAM trial, researchers evaluated the efficacy, safety, and tolerability of 2 doses of oral ozanimod (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI, respectively).
The primary endpoint was the annualized relapse rate over 24 months; secondary endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 24 months; the number of gadolinium-enhancing brain MRI lesions at month 24; and the percent change in whole brain volume.
The topline data that Celgene announced in May 2017 regarding the RADIANCE trial also revealed that the primary endpoint and key secondary MRI endpoints were met.3 The overall safety and tolerability profile was reported to be consistent with results from the SUNBEAM trial and previously reported phase 2 trials.
The European Medicines Agency (EMA) has also accepted for review the marketing authorization application for ozanimod for treatment of adults with relapsing-remitting multiple sclerosis in the European Union. A regulatory decision from the EMA is expected in the first half of 2020.
Ozanimod is currently being studied for other immune-inflammatory indications such as ulcerative colitis and Crohn disease.
1. US FDA and EMA Accept Applications for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis [news release]. Summit, N.J.: Celgene Corporation; June 6, 2019. https://finance.yahoo.com/news/us-fda-ema-accept-applications-113000670.html. Accessed June 6, 2019.
2. Celgene Announces Positive Results from Phase III SUNBEAM Trial of Oral Ozanimod in Patients with Relapsing Multiple Sclerosis [press release]. Summit, NJ: Celgene; Published February 17, 2017. ir.celgene.com/press-releases/press-release-details/2017/Celgene-Announces-Positive-Results-from-Phase-III-SUNBEAM-Trial-of-Oral-Ozanimod-in-Patients-with-Relapsing-Multiple-Sclerosis/default.aspx. Accessed June 6, 2019.
3. Celgene Announces Positive Results from RADIANCE, the Second Pivotal Phase III Trial of Oral Ozanimod in Patients with Relapsing Multiple Sclerosis [news release]. Summit, N.J.: Celgene Corporation; May 22, 2017. https://www.businesswire.com/news/home/20170522005603/en/Celgene-Announces-Positive-Results-RADIANCE-Pivotal-Phase. Accessed June 6, 2019.