BioCentury
ARTICLE | Company News

FDA reschedules meeting for grass allergy products

October 23, 2013 11:55 PM UTC

Stallergenes S.A. (Euronext:GENP) and ALK-Abello A/S (CSE:ALK-B) said FDA's Allergenic Products Advisory Committee will now meet on Dec. 11-12 to discuss BLAs from the companies for two grass pollen allergy products. On Dec. 11, the committee will discuss Stallergenes' Oralair, a sublingual immunotherapy against five grass allergens. On Dec. 12, the committee will discuss a BLA from ALK-Abello's partner Merck & Co. Inc. (NYSE:MRK) for grass Allergy Immunotherapy Tablet (AIT). The committee was originally scheduled to meet on Nov. 5-6 to discuss the products, but FDA postponed the meeting earlier this month due to the shutdown of the federal government.

Stallergenes declined to disclose when it expects a decision from FDA on Oralair, while Merck said it expects a decision on grass AIT in 1H14. The pharma has exclusive rights to develop and commercialize the product in North America from ALK-Abello under a 2007 deal. ALK-Abello markets the tablet-based sublingual allergen immunotherapy as Grazax in Europe (see BioCentury Extra, Oct. 8). ...