FDA panel backs Merck, Stallergenes grass allergy products

FDA's Allergenic Products Advisory Committee voted 9-0 on Thursday that available data support the efficacy of Grastek grass Allergy Immunotherapy Tablet (AIT) from Merck & Co. Inc. (NYSE:MRK) to treat Timothy grass pollen induced allergic rhinitis, with or without conjunctivitis, in individuals five years of age and older. The panel also voted unanimously that available data support the safety of the tablet-based sublingual allergen immunotherapy when administered with the understanding that auto-injected epinephrine will be made available at home.

Merck said it expects an FDA decision on Grastek in 1H14. The pharma has exclusive North American rights to develop and commercialize the product from ALK-Abello A/S (CSE:ALK-B), which markets it as Grazax in Europe. ALK-Abello was up DKK9 to DKK612 on Thursday. The vote came after market close in Denmark. ...