Sanofi's Phase 3 Trials of Multiple Sclerosis Drug Partially Paused by FDA
June 30 2022 - 6:29AM
Dow Jones News
By Pierre Bertrand
Sanofi SA said Thursday that the Food and Drug Administration
has paused some U.S.-based Phase 3 trials of drug tolebrutinib for
treatment of multiple sclerosis and the muscle-weakness condition
myasthenia gravis.
The U.S. regulator based its actions on a limited number of
drug-induced liver injury cases, the French pharmaceutical company
said.
Sanofi said new enrollments in the U.S. have been paused, and
those who have taken part in the trial for fewer than 60 days will
stop taking the drug.
Patients who have completed at least 60 days in the studies
should continue treatment, Sanofi said.
The majority of affected patients were found to have
pre-existing conditions that made them predisposed to drug-induced
liver injuries, which were reversible after discontinuing the drug,
the company said.
Study enrollment outside of the U.S. continues with revised
study protocols and safety monitoring, Sanofi said.
The company said it is still confident in tolebrutinib's
potential as an oral treatment for multiple sclerosis.
Shares at 0945 GMT were down 2.8% at EUR98.07.
Write to Pierre Bertrand at pierre.bertrand@wsj.com
(END) Dow Jones Newswires
June 30, 2022 06:14 ET (10:14 GMT)
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