BioCentury
ARTICLE | Company News

FDA committee to discuss Merck ragweed AIT

December 27, 2013 1:06 AM UTC

FDA's Allergenic Products Advisory Committee will meet on Jan. 28 to discuss a BLA from Merck & Co. Inc. (NYSE:MRK) for Ragwitek ragweed Allergy Immunotherapy Tablet (AIT) to treat ragweed pollen-induced allergic rhinitis, with or without conjunctivitis. The pharma submitted the BLA in March and said it expects a decision in 1H14; a specific action date is not disclosed.

Earlier this 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 expects a decision on Grastek in 1H14 (see BioCentury Extra, Dec. 12). ...