FDA postpones allergenic advisory committee meeting

FDA postponed a Nov. 5-6 meeting of the Allergenic Products Advisory Committee that was scheduled to discuss two grass pollen allergy products due to the shutdown of the federal government. The agency said it postponed the meeting because the subject was allergenics, which are not associated with user fees. Applications for allergenic extract products are not supported by user fees, according to FDA guidance. The agency has said it will continue activities funded by carryover user fee balances during the shutdown, including advisory committee meetings "within the scope of the PDUFA, GDUFA, or MDUFA programs."

The committee was scheduled to discuss a BLA from Stallergenes S.A. (Euronext:GENP) for Oralair, a sublingual immunotherapy against five grass allergens; and a BLA from Merck & Co. Inc. (NYSE:MRK) for grass Allergy Immunotherapy Tablet (AIT). Merck has exclusive rights to develop and commercialize grass AIT in North America from ALK-Abello A/S (CSE:ALK-B), which markets the tablet-based sublingual allergen immunotherapy as Grazax in Europe. ...