Merck & Co has filed a Biologics License Application in the US for its investigational, ALK-partnered* house dust mite pill.
The application is based on results from an extensive clinical development programme involving around 4,400 patients, which formed the basis of the drug’s 11 European approvals thus far, where it is sold by Danish drugmaker ALK under the brand-name Acarizax.
In Europe, the therapy has been cleared for use in adult patients who continue to suffer from allergic rhinitis despite symptom-relieving medication, or when allergic asthma is not well controlled by inhaled corticosteroids.
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.
*ALK is in a strategic partnership with MSD, known as Merck in the USA and Canada, to develop, register and commercialise a portfolio of SLIT tablets against grass pollen, ragweed, and house dust mite allergy in the USA, Canada and Mexico.