Pink Sheet is part of the Informa 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

UsernamePublicRestriction
UsernamePublicRestriction

Sarepta's Eteplirsen Approved After Contentious Internal FDA Debate

Executive Summary

CDER Director Woodcock grants accelerated approval after FDA Commissioner Califf refuses to overturn her finding that the drug's effect on dystrophin is reasonably likely to predict clinical benefit in Duchenne muscular dystrophy.

Advertisement

Related Content

Sarepta Gobbles Up Gene Therapy Partner Myonexus After Early Data Win In Muscular Dystrophy
Lower Drug Costs Might End Perception US FDA Approval Standards Are Lower
Juggling Gene Therapies: Sarepta's Focus Grows, With Many Balls In The Air
Sarepta Commits To Rapid, Thorough Pivotal Study For DMD Gene Therapy Based On Functional Improvements
ODE-1 Director Unger, Not Medical Officer, Conducted Epidiolex Safety Review
Eteplirsen Review Timeline: CDER Director Was Involved Early And Often
Woodcock's Consideration of Sarepta Financial Issues Raises Eyebrows
Sarepta's Eteplirsen Review Delay Emboldens Duchenne Community
Sarepta, FDA And The Dangers Of Strong Early Results
Duchenne Muscular Dystrophy: Second Product Isn't The Charm

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS119160

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel