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

Regeneron’s Arcalyst Gets Advisory Committee For Niche Gout Indication

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Arthritis Advisory Committee will consider the interleukin-1 blocker for prevention of gout flares during initiation of uric-acid lowering therapy. Analysts say Arcalyst could have an easier time than Novartis’ Ilaris, which the panel felt had serious infection safety issues.

You may also be interested in...



Pre-Submission Communication Issues May Hurt Regeneron’s Arcalyst In Gout

FDA warned in pre-submission meetings that the company’s safety database may not be adequate and those questions remain as the application goes to the Arthritis Advisory Committee.

With URL, Takeda Looks To Become U.S. Gout Therapy Provider Of Choice

In purchasing privately held URL for $800 million, Takeda acquires gout drug Colcrys, which it will market alongside Uloric.

With URL, Takeda Looks To Become U.S. Gout Therapy Provider Of Choice

In purchasing privately held URL for $800 million, Takeda acquires gout drug Colcrys, which it will market alongside Uloric.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS073852

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