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

Takeda Avoids REMS For Entyvio, But Must Continue PML Monitoring

This article was originally published in PharmAsia News

Executive Summary

FDA approves drug for ulcerative colitis and Crohn’s disease patients who have failed other therapies, but requires heightened adverse event reporting and post-marketing study.

You may also be interested in...



FDAAA Fading? REMS Use Continues To Decline As Drug Safety Law Matures

FDA’s use of REMS continues to fall to almost undetectable levels, with the agency using the safety tools just a handful of times in the sixth full year of the program. REMS are now very much the exception and not the rule for new products – but still a very important exception.

Vedolizumab, Empagliflozin And Vintafolide Receive Positive EU Opinions After CHMP Meeting

The three new medicines tackle ulcerative colitis and Crohn’s disease, diabetes and ovarian cancer, respectively, with final approval from the European Commission expected in around two months.

Post-Marketing Risk Management An Issue For Takeda’s Entyvio

Advisory committee decides overwhelmingly that PML risk has been adequately characterized, but still wants post-marketing observation. There was no clear decision on the extent of the program needed.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC087190

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