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


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

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

You may also be interested in...

Regeneron Likely Facing New Gout Study Following Arcalyst “Complete Response” Letter

FDA’s decision not to approve rilonacept for preventing gout flares was unsurprising, given its Arthritis Advisory Committee’s unanimous recommendation against the indication. Regeneron says FDA’s letter requests “additional clinical data,” as well as chemistry, manufacturing and controls information.

Regeneron’s Arcalyst Gets Advisory Committee For Niche Gout Indication

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.

Pink Sheet Podcast: US FDA Loses Gene Therapy Expert, Humira Biosimilars Launch, FDA Allows In-Person Meetings

Pink Sheet reporters and editors consider the impact of FDA Office of Tissues and Advanced Therapies Director Wilson Bryan’s retirement, the launch of Humira biosimilars and its effect on the biologic market, as well as the FDA moving to hybrid meetings with sponsors.


Related Companies

Latest Headlines
See All



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