FDA Accepts Merck & Co., Inc.'s BLA for Investigational Allergy Immunotherapy Tablet
Published: Mar 29, 2013
The US FDA has accepted Merck's biologics license application (BLA) for an investigational allergy immunotherapy tablet (AIT), Timothy grass pollen (Phleum pratense). The application includes safety and efficacy data of the investigational sublingual dissolvable tablet from Phase III trials including a long-term, multi-season trial. Merck Research Laboratories senior vice president, global scientific strategy, franchise head, infectious diseases and interim franchise head, respiratory & immunology Jeffrey Chodakewitz said, "We are pleased to have achieved this important milestone in the development of our investigational grass pollen AIT, which, if approved, would represent a potential new option for allergy specialists to offer appropriate allergic rhinitis patients."