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Celgene Just Caught A Major Break From The FDA For Multiple Sclerosis Drug

May 08, 2018 2:33 AM ETCelgene Corporation (CELG)NVS15 Comments


  • Celgene has suffered a refusal-to-file letter from the FDA for ozanimod in multiple sclerosis, but remains on track to file again in Q1 2019.
  • The big reason why the regulatory filing for the FDA was delayed is because regulators were concerned about the half-life of ozanimod.
  • The hematology franchise will more than hold up the delay of approval for ozanimod in multiple sclerosis.
  • Novartis with its multiple sclerosis drug Gilenya may be a competitor, but the safety side of ozanimod is slightly superior.
  • Ozanimod is also expected to be filed for European approval for multiple sclerosis as well by Q1 2019.

Recently, Celgene (NASDAQ:CELG) gave an update for its multiple sclerosis drug ozanimod. It stated that it likely would be able to file early next year. That may seem like a negative, but the management pointed to the fact that another study may not be required. In my opinion, that means a filing could take place by Q1 2019 if everything remains on track. For that reason, I'm bullish on Celgene.

Slight Move

With the new announcement by Celgene on its MS drug ozanimod, it means that a regulatory filing could take place sometime in early 2019. This is not bad when you think about it. The original filing date expected by Celgene for ozanimod was Q3 2018. So in essence, it was pushed up two quarters. I understand why investors would not be happy about this, but the recent news of not needing another study should be seen as a major positive. As much as many would have loved to see ozanimod approved a lot quicker, it is better that the company takes its time to make sure all safety issues are accounted for. The big reason for the delay is due to ozanimod's chemical structure in which it has a long half-life of 10 to 13 days. When it is metabolized in humans it forms as one major active metabolite and a few other minor active metabolites. The half-life is the amount of time it takes for a biological substance to be degraded in the body by half. The rate of removal during the breakdown process is exponential. In my opinion, the FDA is being cautious.

When The Problem Started

The issue started when the FDA gave Celgene a refusal-to-file letter back in February of 2018. The FDA refused to file Celgene's application, because of insufficient information for ozanimod. More specifically, the

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