Merck’s ALK-partnered house dust mite allergy pill MK-8237 is a step closer to the US market after regulators said they would consider its approval for treating allergic rhinitis with or without conjunctivitis caused by such allergens.
The US Food and Drug Administration has accepted for review the firm’s Biologics License Application for the dust mite sublingual allergy immunotherapy (SLIT) tablet, based on data from an extensive clinical development programme involving around 4,400 patients.
An approval in the US would broaden Merck’s offering of sublingual allergy immunotherapy (SLIT) tablets, adding to grass pollen allergy fill Grastek and Ragwitek for short ragweed pollen induced allergic rhinitis.
House dust mites are one of the most common causes of allergy, likely affecting more than 200 million people worldwide. The condition appears early in life and is present all year round, and nearly 50% of all house dust mite-allergic rhinitis patients suffer from concomitant asthma.
The drug has racked up 11 approvals in Europe so far, where it is sold by Danish drugmaker ALK under the brand-name Acarizax.