Pink Sheet 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

Enbrel REMS delays pediatric approval

Executive Summary

Amgen received a "complete response" letter from FDA on Enbrel (etanercept) in pediatric patients with moderate to severe plaque psoriasis, the biotech announces July 24. The tumor necrosis factor inhibitor would be the first FDA-approved treatment for the indication. FDA has requested additional information related to the Risk Evaluation and Mitigation Strategy for Enbrel in pediatric psoriasis, Exec VP-R&D Roger Perlmutter says during a second quarter earnings call July 28. Amgen is also working out a REMS strategy with FDA for the platelet drug Nplate (romiplostim), which had a July 23 user fee date. "REMS programs are becoming increasingly important in our interactions with the FDA," Perlmutter says. FDA is setting precedents with every REMS - a new part of the regulatory process - and has extended or missed several user fee deadlines as a result

Related Content

UsernamePublicRestriction

Register

PS049941

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