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news.Regeneron Pharmaceuticals has announced that the Arcalyst injection for subcutaneous use is available for prescription in the US for the treatment of cryopyrin-associated periodic syndromes, including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome in adults and children 12 and older.
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Regeneron was granted marketing approval for Arcalyst by the FDA in February 2008, making it the only therapy approved for patients with cryopyrin-associated periodic syndromes (CAPS), a group of rare, inherited, auto-inflammatory conditions characterized by life-long symptoms of rash, fever or chills, joint pain, eye redness or pain, and fatigue.
Arcalyst is being distributed through two specialty pharmacies, which will directly mail patients a monthly shipment of Arcalyst and the supplies needed for self-injection. The pharmacies will also provide access to self-injection training and adherence counseling to patients who need those services.
Leonard Schleifer, president and CEO of Regeneron, said: “Recognizing the painful, isolated lives experienced by patients with CAPS, we are pleased that we can offer these patients an FDA-approved therapy that helps control its debilitating symptoms.”