US FDA approves ALK and Merck's Grastek sublingual tablet for grass allergy

The US Food and Drug Administration has approved the Biologic License Application (BLA) for Grastek (Timothy grass pollen allergen extract) sublingual allergy tablet from Denmark-based allergy specialist ALK Abello (ALKB: DC).

Grastek is the US trade name of the grass SLIT-tablet which is licensed to pharma giant Merck & Co (NYSE: MRK) for North America by ALK, and marketed in Europe under the brand name Grazax. Grastek is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens.

Jens Bager, president and chief executive of ALK, said: “With the FDA approval of Grastek/Grazax, US patients who suffer from moderate to severe grass allergy will now gain access to effective, convenient and well documented allergy treatment. 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.”