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news.Regeneron Pharmaceuticals has received marketing approval from the FDA for Arcalyst subcutaneous injection for the treatment of cryopyrin-associated periodic syndromes or CAPS, including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome in adults and children 12 and older.
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Arcalyst is a targeted inhibitor of interleukin-1 (IL-1), the key driver of inflammation in CAPS. Regeneron expects to launch Arcalyst, its first commercial product, within the next 30 days.
Leonard Schleifer, Regeneron’s president and CEO, said: “This approval exemplifies company’s commitment to discover, develop, and commercialize important medicines for patients suffering from serious diseases, such as CAPS.”