Tagged: avexis, avxs-101, experimental therapies, FDA, Novartis, research, SMA News Today YouTube channel, SMA type 1, The Morale Monologue, zolgensma
This topic has 3 replies, 3 voices, and was last updated 2 years, 2 months ago by Kevin Schaefer.
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December 12, 2018 at 7:04 am #16027
Michael Morale
KeymasterIn 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.
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December 12, 2018 at 10:37 am #16056
Kevin Schaefer
KeymasterThanks 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.
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December 13, 2018 at 12:29 pm #16087
Adnan Hafizovic
ParticipantBut this cure is just for people with type 1?
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December 13, 2018 at 12:42 pm #16089
Kevin Schaefer
KeymasterAdnan, 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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