FDA panel backs Merck ragweed allergy product

FDA's Allergenic Products Advisory Committee voted 6-2, with one abstention, that available data support the efficacy of Ragwitek ragweed Allergy Immunotherapy Tablet (AIT) from Merck & Co. Inc. (NYSE:MRK) to treat ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, in patients 18 to 65 years of age. The panel also voted 8-0, with one abstention, that available data support the safety of Ragwitek. Merck expects a decision this half, but a specific action date is not disclosed.

Last month, the advisory committee voted unanimously that available data support the efficacy of Merck's Grastek grass AIT to treat Timothy grass pollen-induced allergic rhinitis, with or without conjunctivitis. Merck also expects a decision on Grastek this half (see BioCentury Extra, Dec. 12, 2013). ...