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AveXis' AVXS-101 SMA Therapy Delayed To 2019?

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This topic has 0 replies, 1 voice, and was last updated 2 years, 9 months ago by Anonymous.

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    • #10966

      There’s no doubt that the SMA community is anticipating AveXis’ AVXS-101 as a possible follow-up and complement to Spinraza. Recent news suggests, however, that, based on what’s going on between AveXis and the FDA, any possible approval might not be coming until 2019. In a new report, AveXis notes that they hope to “request a pre-BLA meeting in the second quarter of 2018,” which would suggest that any approval or launch would happen in 2019, not 2018.

      While this isn’t great news from a timing perspective, it doesn’t affect the viability of AVXS-101 as a possible approved therapy, and we know from experience with the Spinraza approval that the FDA will do what it can to approve the therapy asap.

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