Dust Mite Allergy Immunotherapy Tablet Under Review

The FDA has accepted for review Merck's biologics license application for a dust mite sublingual allergy immunotherapy tablet.

The FDA has accepted for review Merck’s biologics license application for a dust mite sublingual allergy immunotherapy tablet.

If approved, MK-8237 could potentially help individuals with dust mite-induced allergic rhinitis with or without conjunctivitis.

The FDA based its decision to accept the application for review on data from a clinical program involving more than 4000 patients. Two phase 3 studies evaluated the efficacy and safety of MK-8237 in individuals with dust mite-induced allergic rhinitis with or without conjunctivitis.

“We are proud of Merck’s longstanding respiratory heritage and commitment to helping patients with allergies,” said Stuart Green, MD, vice president, clinical research, Merck Research Laboratories, in a press release. “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.”

Dust mites can cause a series of allergy symptoms ranging from sneezing, coughing, runny nose, and watery eyes.

Merck partnered with ALK-Abelló to delop the tablet, which is dissolvable.