Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Takeda Febuxostat Benefits Outweigh CV Risk; Will Other Gout Drugs Follow?

Executive Summary

Strong efficacy data and a desperate need for new gout therapies outweigh the potential cardiovascular risk associated with Takeda's febuxostat, an FDA advisory committee determined in recommending approval of the drug during a Nov. 24 meeting

You may also be interested in...



Waiting For Next Regulatory Shoe To Drop For Takeda's Gout Drug Uloric

FDA already issued a warning based on preliminary data from the CARES outcomes study, but now the final results of the confirmatory trial are in and show higher risk for cardiovascular death for Uloric compared with generic allopurinol.

Savient Suggests More Restrictive REMS For Pegloticase In BLA Amendment

Savient has made a clever anticipatory move that could help avoid a "complete response" letter for its BLA for pegloticase, a therapy for treatment-failure gout. The firm submitted major amendments just one month prior to its scheduled advisory committee hearing, including a revised proposed Risk Evaluation and Mitigation Strategy that adds a certification program

Savient Suggests More Restrictive REMS For Pegloticase In BLA Amendment

Savient has made a clever anticipatory move that could help avoid a "complete response" letter for its BLA for pegloticase, a therapy for treatment-failure gout. The firm submitted major amendments just one month prior to its scheduled advisory committee hearing, including a revised proposed Risk Evaluation and Mitigation Strategy that adds a certification program

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS050398

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