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Merck & Co Inc Announces FDA Acceptance of Biologics License Application for Investigational Grass Pollen Allergy Immunotherapy Tablet


Wednesday, 27 Mar 2013 08:00am EDT 

Merck & Co Inc announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA). In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT. The BLA for Merck`s grass pollen AIT is supported by Phase III trials that evaluated the safety and efficacy of the investigational product, including a long-term, multi-season trial. Merck's grass pollen (Phleum pratense) AIT 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 targeted allergens. Merck has partnered with ALK-Abello to develop its grass pollen (Phleum pratense) AIT in North America.