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


Regeneron plans to file Arcalyst for gout flares in mid-2011

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Regeneron reported mixed results June 9 for its investigational gout therapy Arcalyst (rilonacept/IL-1 Trap). In the Phase III study PRE-SURGE 1, which evaluated the number of gout flares per patient over the first 16 weeks following initiation of allopurinol therapy, the interleukin-1 inhibitor met the primary and all secondary endpoints. Patients receiving 160 mg weekly experienced an 80 percent decrease in mean number of flares compared to placebo, and patients receiving the 80 mg dose experienced a 73 percent decrease. It was well-tolerated with no serious adverse events. The company plans to file Arcalyst in that indication in mid-2011 if data from two ongoing studies are successful. Both a second efficacy study and a 1,000-patient safety study are expected to report early next year. The second study reported June 9 evaluated the effectiveness of adding Arcalyst to the non-steroidal anti-inflammatory indomethacin in patients experiencing acute gout flare; the combination showed no pain benefit compared to the NSAID alone. Arcalyst will be the first of the new wave of gout drugs to take on the task of relieving painful flares that happen when uric acid lowering drugs start to affect serum uric acid levels (1Pharmaceutical Approvals Monthly, November 2009)

You may also be interested in...

As Gout Market Opens Up, Experts Await Therapies To Better Lower Uric Acid

PHILADEPHIA – Though Takeda's gout therapy Uloric (febuxostat) has broken a 40-year dry spell in the market, physicians and researchers are hoping more drugs will be approved that can reduce serum uric acid well below the standard 6 mg/dL benchmark. Safety, though, could be a hang-up.

Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

Liquid Biopsy Company Delfi Diagnostics Raised $100M For New Class of Early Cancer Detection Test

Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials. 





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