The Morale Monologue #14 – The FDA Announces Acceptance And Priority Review For AVXS 101

[Michael Morale]

In this episode of the Morale Monologue, I’m going to read an article that was posted to the Cure SMA website on Monday, December 3, 2018. The article is entitled Novartis Announces FDA Filing Acceptance and Priority Review For AVXS-101. As most of you know, Biogen was awarded Fast-Track status by the FDA for their drug Spinraza. Avexis’s drug AVXS-101, now known as ZOLGENSMA, was awarded Priority Review designation, which is essentially the same thing as Fast-Track status. The once anticipated acceptance by the FDA was due between June and September of 2019, but since they were awarded Priority Review designation, ZOLGENSMA is now anticipated to receive final approval by the FDA in May 2019. Priority Review designation means the FDA’s goal is to take action on an application within six months, compared to 10 months under standard review.

I am reading the article verbatim from the Cure SMA website, and a link to this article can be found just here: Cure SMA Article: http://www.curesma.org/news/novartis-avexis-bla-acceptance.html

 

Be sure to subscribe to the SMA News Today YouTube channel so that you don’t miss an episode of this vlog, and you can also connect with me right here on the forums page.

[Kevin Schaefer]

Thanks Michael! It’s definitely an exciting time for the SMA community. I wrote about this topic as well in my latest column: https://smanewstoday.com/2018/12/11/sma-research-advancements-grateful-patience/?amp.

[Adnan Hafizovic]

But this cure is just for people with type 1?

[Kevin Schaefer]

Adnan, Michael and I go into detail about if this treatment will be available for other SMA types in this podcast. Give it a listen here: https://smanewstoday.com/forums/forums/topic/sma-news-today-podcast-episode-20-roundtable-discussion-avxs-101/.

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