The U.S. Food and Drug Administration (FDA) has approved the Biologic License Application of Merck's grass pollen sublingual allergy immunotherapy medication named Grastek.
On Monday, ALK announced that Grastek's Biological License Application for Grastek has finally been approved.
"With the FDA approval of GRASTEK [for the United States] and GRAZAX [for Europe] , US patients who suffer from moderate to severe grass allergy will now gain access to effective, convenient and well documented allergy treatment," said Jens Bager, president and chief executive officer of ALK, on a press release.
He added, "Merck is now able to launch the first of ALK's tablets in the USA - the world's largest pharmaceutical market. This is another major step on our journey towards commercializing our portfolio of SLIT-tablets globally."
Grastek, which is an allergen extract, is indicated as an immunotherapy treatment for the grass pollen-induced allergic rhinitis with or without the presence of conjunctivitis. As long as it is confirmed by a positive skin test or in vitro testing for pollen-specific IgE antibodies for cross-reactive grass pollens, or Timothy grass.
The joint venture of ALK and Merck covers the advancement, registration and commercialization of a collection of sublingual allergy immunotherapy tablets in the North America. The approval of Grastek in the United States warrants ALK to a milestone payment from the New Jersey-based pharmaceutical company.
Aside from the grass pollen medication, the FDA is currently looking at and reviewing Merck's Biological License Application for a sublingual allergy immunotherapy tablet against ragweed allergy, and it is called Ragwitek. The decision of the FDA is expected to come out sometime before the second quarter of 2014 ends.
According to the Centers for Disease Control and Prevention, about 17.6 million adults, or 7.5 percent of the population, in the United States were diagnosed with grass allergy in the past 12 months. It also affects about 6.6 million children which come second as the most common allergy after skin allergies.
