-- FDA placed a partial hold on AVXS-101 intrathecal clinical trials for SMA patients based on findings in a small pre-clinical animal study -- Adverse events that might be expected from the pre-clinical findings have not been seen in a thorough review of human safety data from all available sources to date -- Zolgensma(R) (onasemnogene abeparvovec-xioi) also known as AVXS-101 intravenous administration is not impacted and remains available in the US -- Novartis is working with FDA to determine next steps to release partial hold and resume dosing in the AVXS-101 intrathecal trials https://www.marketscreener.com/NOVARTIS-9364983/news/NOVARTIS-CHF0-50-REGD-Novartis-Announces-Avxs-101-Intrathecal-Study-Update-29479214/
Search This Blog
Wednesday, October 30, 2019
Novartis Announces Avxs-101 Intrathecal Study Update
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.