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

Tysabri’s PML Risk Quantified In Revised Label; Can Added Certainty Add Scripts?

This article was originally published in The Pink Sheet Daily

Executive Summary

Multiple sclerosis and Crohn’s disease patients with anti-JC virus antibodies who have previously taken other immunosuppressants have a 1.1% risk of developing the deadly neurological condition after taking Biogen Idec /Elan’s Tysabri for more than two years.

You may also be interested in...



Tysabri Liability: Biogen's Dialogue With FDA Helps Get Suit Tossed

Judge finds Tysabri label warnings about brain infection were adequate and that there is 'clear evidence' FDA would not have approved a labeling change.

Legacy Cost: Takeda’s Entyvio Development Shaped By Tysabri Fallout

The specter of Tysabri and its restrictive REMS loomed over the review of Takeda’s Entyvio, making for an unusually high level of communication and discussion from Phase II until late in the review cycle – a tally that includes 14 pre-BLA face-to-face meetings between FDA and the sponsor, as well as two advisory committee reviews and two turns before FDA’s REMS Oversight Committee.

Biogen Idec Suggests PML Risk Manageable For Tecfidera, After Reporting First Case

Deadly brain disease casts shadow over a quarter in which the company reports progress on new launches, including hemophilia, but PML occurred in only one in 100,000 treated and experience suggests risk can be managed.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM005224

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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