|
 Shares of the company rose 24 percent to $19.90 in extended trading
on Monday.
The FDA deferred a highly anticipated decision on whether to approve
Sarepta's drug, eteplirsen, last month, after an advisory panel
determined that the treatment was not effective.
The agency requested that Sarepta provide dystrophin data from
biopsies already obtained from the ongoing confirmatory study of
eteplirsen, the company said on Monday.
Sarepta's drug has been in the spotlight over the past few months
with patient groups and parents arguing passionately in favor of the
treatment to pressure the regulator to approve the drug.
Duchenne muscular dystrophy is a rare genetic disorder characterized
by progressive muscular weakness and is caused by a lack of
dystrophin, a protein needed to keep muscles healthy. Eteplirsen is
designed to increase the production of dystrophin.
Sarepta said on Monday that it plans to submit data from thirteen
patient biopsy samples to the FDA over the coming weeks to
facilitate a prompt decision by the agency.
[to top of second column] |
(Reporting by Ankur Banerjee in Bengaluru; Editing by Shounak
Dasgupta)
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