-- 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/
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Wednesday, October 30, 2019
Novartis Announces Avxs-101 Intrathecal Study Update
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