ALK’s partner for North America, MSD (known as Merck in the United States and Canada), announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet for review. MSD submitted the BLA, for a tablet against HDM allergy, to the FDA in February 2016.
The application to the FDA is based on results from an extensive clinical development programme that has involved approximately 4,400 patients in North America and Europe and has already seen the product approved in 11 European countries, where it is known as ACARIZAX®. The product has also been launched in Japan, where it is marketed by Torii under the brand name MITICURETM.
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.
ALK’s partnership with MSD covers the development, registration and commercialisation of a portfolio of allergy immunotherapy tablets in North America.
