Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet has been accepted for review by the U.S. Food and Drug Administration (FDA). On March 27, Merck announced that the FDA had also accepted the BLA for its investigational Timothy grass pollen (Phleum pratense) sublingual allergy immunotherapy tablet. Merck expects the FDA's review for both to be completed in the first half of 2014.
“Merck has a long history of developing new therapies to help patients with allergic rhinitis”
The BLA for Merck's investigational ragweed pollen sublingual allergy immunotherapy tablet is supported by five studies evaluating the efficacy and safety of the tablet in adults, 18 years of age or older, with ragweed induced allergic rhinitis (with or without conjunctivitis).
"Merck has a long history of developing new therapies to help patients with allergic rhinitis," said Jeffrey A. Chodakewitz, M.D., senior vice president, interim franchise head, Respiratory & Immunology, Merck Research Laboratories. "This regulatory milestone for our investigational ragweed pollen sublingual allergy immunotherapy tablet represents another step in our continued commitment to offering potential new options to allergy specialists and their patients."
Merck's ragweed pollen sublingual allergy immunotherapy tablet is an investigational sublingual dissolvable tablet designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect against the targeted allergen. Merck has partnered with ALK-Abello to develop its sublingual allergy immunotherapy tablets for ragweed pollen, timothy grass pollen and house dust mite in North America.