Drug news

FDA accepts BLA for MK-8237 dust mite sublingual allergy immunotherapy (SLIT) tablet- Merck

Read time: 1 mins

Last updated:13th Apr 2016

Published:13th Apr 2016

Source: Pharmawand

Merck announced that the FDA has accepted for review the Biologics License Application (BLA) for MK-8237, Merck’s house dust mite sublingual allergy immunotherapy (SLIT) tablet. The BLA for Merck's investigational SLIT-tablet is supported by a comprehensive clinical programme involving more than 4,000 patients, including two Phase III in-field trials that evaluated the efficacy and safety of MK-8237 in house dust mite-induced allergic rhinitis with or without conjunctivitis.

MK-8237 is an investigational sublingual immunotherapy dissolvable tablet designed to help treat allergic rhinitis with or without conjunctivitis caused by house dust mite-specific allergens. Merck has partnered with ALK-Abelló to develop its house dust mite SLIT-tablet in North America.

Comment: A US approval would add to Merck’s SLIT tablets Grastek/Grazax for grass pollen allergy and Ragwitek for short ragweed pollen induced allergic rhinitis.

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