Unanimous FDA panel support for Merck & Co’s Grastek

The Allergenic Products Advisory Committee (APAC) of the US Food and Drug Administration yesterday voted unanimously that the available data support the efficacy and safety of Merck & Co’s (NYSE:MRK) Grastek (Grazax) in patients aged five to 65 years.

The committee further recommended that adrenaline auto-injectors should be made available for patients at home, reported Denmark’s ALK Abello (ALK: DC), partner and originator the of product. Grastek is the proposed US trade name of the grass sublingual allergy immunotherapy tablet, licensed to Merck for North America by ALK, and marketed in Europe under the brand name Grazax.

The FDA is currently reviewing Merck’s Biologic License Application for Grastek for the treatment of grass pollen induced allergic rhinitis, with or without conjunctivitis, in adults and children of five years and older. The APAC a day earlier backed approval of Oralair, a grass pollen allergy product from France’s Stallergenes ((GENP: FP; The Pharma Letter December 12).