ALK, a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment, has announced that due to the U.S. government shutdown, the FDA has temporarily postponed the Allergenic Products Advisory Committee meeting scheduled for Nov. 6 to discuss the Biologic License Application (BLA) for the investigational grass allergy immunotherapy (AIT) tablet. The FDA has not yet confirmed a new date for the Advisory Committee meeting.
FDA advisory committees are panels of independent experts who advise the agency as it considers regulatory decisions. Advisory committee meetings are open to the public and are common for new drug classes and/or major pharmaceutical drugs under review.
In January, ALK's North American partner Merck submitted the BLA to the FDA for the disease-modifying tablet against grass pollen allergy. In March, ALK and Merck announced the BLA was accepted for review by the FDA.
ALK's partnership with Merck covers the development, registration and commercialization of a portfolio of allergy immunotherapy tablets in North America.