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FDA accepts biologics license application for MSD’s allergy immunotherapy drug

Published on 13/04/16 at 09:02am

MSD (NYSE: MRK) has announced that the US Food and Drug Administration has accepted for review the biologics license application for MK-8237, its sublingual allergy immunotherapy (SLIT) tablet for house dust mite allergies.

This application heavily draws on two Phase III clinical trials, involving more than 4,000 patients, which evaluated the efficacy and safety of MK-8237 in house dust mite-induced allergic rhinitis with or without conjunctivitis.

Stuart Green, VP of clinical research at MSD, says: “We are proud of Merck’s longstanding respiratory heritage and commitment to helping patients with allergies. This is an important milestone in the clinical development of MK-8237 as a potential new option for adults with house dust mite-induced allergic rhinitis with or without conjunctivitis. House dust mites are a source of a common perennial allergen and frequently live in household objects such as upholstered furniture, bedding and carpeting.”

MSD partnered with ALK-Abelló to develop its house dust mite SLIT-tablet in North America.

Sean Murray

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