Regeneron Likely Facing New Gout Study Following Arcalyst “Complete Response” Letter
This article was originally published in The Pink Sheet Daily
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.
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A startup called Crealta Pharmaceuticals will acquire most of Savient’s assets, including the marketed gout drug Krystexxa, for $120.4 million following a bankruptcy court auction.
With other companies struggling to develop new gout therapies, Savient is hoping to develop a partnering strategy for Krystexxa in markets outside the U.S. as well as broaden use of the injectable biologic in different categories of patients.
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.