The US Food and Drug Administration (FDA) has sent Celgene Corporation a “refusal to file” letter regarding its New Drug Application (NDA) for ozanimod for treatment of patients with relapsing multiple sclerosis (RMS), the company said.
In its preliminary review, the FDA determined that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review, the company explained in a news release.
Celgene said it would seek immediate guidance from the FDA to determine what additional information they require to resubmit the NDA.
“We remain confident in ozanimod’s clinical profile demonstrated in the pivotal program in relapsing forms of multiple sclerosis,” Jay Backstrom, MD, chief medical officer and head of global regulatory affairs for Celgene, said in the release. “We will work with the FDA to expeditiously address all outstanding items and bring this important medicine to patients,” he added.
Ozanimod is an oral once-daily immunomodulator that selectively targets sphingosine 1-phosphate 1 (S1P) and 5 receptors, in development for several immune-inflammatory indications, including RMS, ulcerative colitis, and Crohn’s disease.
Ozanimod was recently found to be safe and effective in patients with RMS in the phase 3 SUNBEAM and RADIANCE trials.
Full data from both multicenter, randomized controlled trials were presented at the Joint European Committee for Treatment and Research in Multiple Sclerosis-Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2017 meeting, and reported by Medscape Medical News.
In SUNBEAM, which included more than 1300 patients, those who received once-daily ozanimod 0.5 mg or 1 mg for 1 year had significantly greater reductions in annualized relapse rate (ARR, the primary endpoint) than did patients who received weekly 30-µg intramuscular injections of interferon β-1a (IFN; Avonex, Biogen).
MRI findings showed that the ozanimod group also had greater reductions in gadolinium-enhancing lesions and new or enlarging T2 lesions.
In RADIANCE part B, which also included more than 1300 patients with RMS, the groups receiving 0.5 or 1 mg of ozanimod daily had greater ARR reductions at 2 years than the group receiving IFN.
In addition, the number of new or enlarging T2 lesions was reduced by 34% and 42% for the two doses, respectively, compared with IFN, and the number of gadolinium-enhancing lesions was reduced by 47% and 53%.
In both trials, there were few serious adverse events, which did not differ significantly between treatment groups. No serious cardiac-related adverse events, serious opportunistic infections, or treatment-related deaths occurred.
Ozanimod is an investigational compound that is currently not approved for any use in any country.
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