FDA accepts Celgene’s ozanimod application; Lilly’s cluster headache drug gets nod

By PharmaCompass

2019-06-13

Impressions: 208 Article

The US Food and Drug Administration (FDA) has accepted Celgene’s once rejected application for ozanimod, an experimental therapy for multiple sclerosis. Fifteen months ago, FDA’s refuse-to-file on the ozanimod application had triggered a collapse of faith in Celgene.

In fact, Celgene reported that both the FDA as well as the EMA have accepted the application for ozanimod. Though the acceptance does in no way guarantee approval, it does set the clock ticking on a major regulatory decision that is central to the success of the US$ 74 billion Celgene buyout by Bristol-Myers Squibb (BMS). In January, BMS acquired Celgene for around US$ 74 billion.

The EMA decision (on approval of ozanimod) will come in the first half of 2020. The FDA is also likely to decide on the drug by March 25, 2020 (which marks the PDUFA deadline for the US regulator to review new drugs).

Meanwhile, in a high-level reorganization, BMS has retrenched its chief scientific officer (CSO) Tom Lynch, who was brought in just two years back. The company said Lynch will leave his post as

CSO in four months. Celgene’s R&D executive Rupert Vessey will move into his position. Novartis’ oncology development head Samit Hirawat will join BMS as chief medical officer.

Lilly’s headache drug: Eli Lilly’s migraine treatment Emgality became the first drug to gain FDA approval for decreasing the frequency of episodic cluster headache attacks.

Emgality belongs to a new class of drugs called CGRP inhibitors, used to prevent migraines or reduce their frequency. It competes with Ajovy from Teva and Amgen’s Aimovig.

Cluster headaches are recurring, intense headaches that can occur several times daily during a “cluster period.” Lilly estimates that around 250,000 people suffer from the condition in the United States.

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