Celgene to re-file Ozanimod in 1st quarter of 2019

As per Celgene, Submission of NDA and MAA for ozanimod in relapsing multiple sclerosis expected in Q1:19

Celgene in its recent interaction with analysts have highlighted that the company expects to resubmit the NDA for Ozanimod in the first quarter of 2019. The company further assured the analysts that following a meeting with European regulatory authorities, Celgene expects to submit a Marketing Authorization Application (MAA) for ozanimod in RMS in the first quarter of 2019.

In February, Celgene announced it received a Refusal To File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for ozanimod in relapsing multiple sclerosis (RMS). Following a Type A meeting with the FDA in early April, Celgene expects to resubmit the NDA in the first quarter of 2019. Following a meeting with European regulatory authorities, Celgene expects to submit a Marketing Authorization Application (MAA) for ozanimod in RMS in the first quarter of 2019.

At the 2018 American Academy of Neurology (AAN) Annual meeting in April, data from new analyses of both pivotal phase III SUNBEAM™ and RADIANCE™ Part B trials evaluating ozanimod in RMS were presented. These new analyses show dose-dependent effects of ozanimod on annualized relapse rate (ARR) versus interferon beta-1a (Avonex®) across subgroups, including baseline disability and prior exposure to disease-modifying therapies, that were consistent with the overall ARR primary endpoint. In addition, data presentations of exploratory endpoints showed reductions in cortical grey matter and thalamic volume loss consistent with the reductions in whole brain volume loss seen in SUNBEAM™ at one year and RADIANCE™ Part B at two years for ozanimod compared with Avonex®. The overall safety and tolerability profile for ozanimod has been consistent across the RADIANCE™ Part A, SUNBEAM™ and RADIANCE™ Part B studies.

This update from Celgene should give some relief to the stakeholders and the analysts as Celgene has managed to reduce the gap between the re-filing of Ozanimod and the original filing date, which was expected to be in 3^rd quarter of 2018.

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News Source: Celgene Website

Image Source: https://www.in-pharmatechnologist.com/Article/2018/05/08/FDA-approves-simultaneous-administration-of-Tafinlar-Mekinist-for-ATC