With URL, Takeda Looks To Become U.S. Gout Therapy Provider Of Choice
This article was originally published in PharmAsia News
In purchasing privately held URL for $800 million, Takeda acquires gout drug Colcrys, which it will market alongside Uloric.
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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.
FDA asks Mutual to stop using a pharmacy sell sheet that describes the gout drug as “gentle.” It also cites a video for failing to convey serious risk information and suggesting the drug is as tolerable as a placebo and superior to NSAIDs.
The agency will also ask its Arthritis Advisory Committee at a June 21 meeting whether the sponsor should explore lower doses for the interleukin-1 beta inhibitor.