The US Food and Drug Administration (FDA) has accepted Merck's biologics license application (BLA) for its investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet. The 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, known as MSD outside the United States and Canada, announced that on March 27, 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.

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, MD, 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 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.

Merck is a global healthcare leader working to help the world be well. Through its prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions.