Merck & Co. Inc. (MRK) announced Wednesday that the Biologics License Application or BLA for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet or AIT has been accepted for review by the U.S. Food and Drug Administration or 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 said that its 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.
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