ALK Announces Merck Submits BLA to FDA for Investigational House Dust Mite SLIT-tablet
ALK (OTC: AKABY) (OTC: AKBLF) announced today that its partner for North America, MSD (known as Merck (NYSE: MRK) in the United States and Canada) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its house dust mite (HDM) sublingual allergy immunotherapy tablet (SLIT-tablet).
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(r). The product has also been launched in Japan, where it is marketed by Torii under the brand name MITICURETM.
Jens Bager, President & CEO of ALK, said: "If the investigational HDM SLIT-tablet is approved in the USA, it would allow MSD to offer a broader portfolio of SLIT-tablets to the physicians and patients following the approvals of GRASTEK(r) and RAGWITEK(r) in 2014."
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.
The submission of