FDA Advisory Committee recommends approval of Grastek for Allergy-Merck

Merck Inc has announced that the FDA's Allergenic Products Committee has voted unanimously to recommend Grastek (sublingual Timothy Grass pollen allergen extract tablet) for the treatment of Timothy grass pollen�induced Allergic Rhinitis, with or without Conjunctivitis, in individuals aged 5 to 65 years, with the understanding that autoinjected epinephrine will be available to patients at home. The drug has been on the market in Europe since 2006 under the trade name Grazax.

The vote is based on data from five Phase I studies, two Phase II studies, six Phase III studies, and 2 identified as Phase III European studies. The primary efficacy endpoint in the Phase III efficacy studies was the average rhinoconjunctivitis (RC) daily symptom score, the average RC daily medication score, or the average combined RC daily symptom score and daily medication score during the entire grass pollen season. The drug met the primary endpoints in the first grass pollen season in 3 of the 4 confirmatory efficacy trials, but not in the first North American trial.