October 30, 2019 / 6:47 AM / 21 days ago

BRIEF-Novartis Says FDA Placed Partial Hold On Avxs-101 Intrathecal Trials For SMA Patients

Oct 30 (Reuters) - Novartis AG:

* NOVARTIS ANNOUNCES AVXS-101 INTRATHECAL STUDY UPDATE

* 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 PRE-CLINICAL FINDINGS HAVE NOT BEEN SEEN IN A THOROUGH REVIEW OF HUMAN SAFETY DATA FROM ALL AVAILABLE SOURCES TO DATE

* ZOLGENSMA® (ONASEMNOGENE ABEPARVOVEC-XIOI) ALSO KNOWN AS AVXS-101 INTRAVENOUS ADMINISTRATION IS NOT IMPACTED AND REMAINS AVAILABLE IN US

* NOVARTIS IS WORKING WITH FDA TO DETERMINE NEXT STEPS TO RELEASE PARTIAL HOLD AND RESUME DOSING IN AVXS-101 INTRATHECAL TRIALS Further company coverage: (Berlin Speed Desk)

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