Novartis Gets FDA Approval to Proceed With Trials for Muscular Atrophy Treatment
03 Agosto 2021 - 07:59AM
Dow Jones News
By Chris Wack
Novartis AG said the U.S. Food and Drug Administration has
determined that OAV-101 intrathecal clinical trials for spinal
muscular atrophy patients can proceed, lifting the partial clinical
trial hold initiated in October 2019.
The company said the decision to lift the hold was based on data
from its nonclinical toxicology study in non-human primates that
addressed all issues identified, including questions of dorsal root
ganglia injury following IT administration.
Following the decision and input from the FDA and European
Medicines Agency, Novartis plans to initiate a global Phase 3
registration-enabling study to evaluate the clinical efficacy,
safety, and tolerability of OAV-101 IT in treatment naive patients
who are between two and 18 years of age, able to sit, but have
never walked.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
August 03, 2021 06:45 ET (10:45 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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