Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

Data Trumps Anecdotes, Emotion At Sarepta Panel

Executive Summary

At a highly charged April 25 meeting of the FDA's Peripheral and Central Nervous System (PCNS) Advisory Committee, which concluded with angry shouting from parents and patient advocates, a majority of panelists said Sarepta Therapeutics Inc. failed to provide sufficient efficacy data for its Duchenne muscular dystrophy drug eteplirsen to win US approval – accelerated or standard, although the votes were much closer on the former than on the latter question.

Advertisement

Related Content

Stockwatch: Earnings Move From Mediocre to Worse
Sarepta Lashed Again; More Duchenne Market Doubt

Topics

Advertisement
UsernamePublicRestriction

Register