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The Morale Monologue #11 – Avexis Files For FDA Approval Of Their Drug AVXS101
In this episode of the Morale Monologue, I’m going to discuss Avexis Pharmaceutical’s recent FDA filing for approval of their drug known as AVXS-101. A few years ago, Biogen Pharmaceuticals filed their Biologics License Agreement (BLA) with the FDA to make their drug, Spinraza, the first FDA approved treatment for those of us who suffer from SMA. Now, Avexis Pharmaceuticals has filed their BLA in hopes that the FDA will approve their drug AVXS-101, and make it the second FDA approved treatment for SMA.
Avexis also filed their paperwork in Europe and in Japan, and their hopes are to have this drug approved in all three countries by the middle of 2019. Given the fact that there will possibly be two FDA approved treatments for those of us who suffer from SMA, we have a lot to look forward to and we have reasons to be excited.
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1 Reply
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Changing the face of SMA as we know it. What an exciting time for the SMA community.
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