Scrip is part 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

Spotlight On Sarepta Post-BioMarin Duchenne Rejection

This article was originally published in Scrip

Executive Summary

It was highly likely the FDA was going to turn down BioMarin Pharmaceutical Inc. on its Duchenne muscular dystrophy (DMD) drug Kyndrisa (drisapersen), given the beating it took this past November at the meeting of the agency's Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee and the fact regulators had earlier called the firm's data "inconsistent," and in some cases, "contradictory."

Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

SC064228

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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