Merck announced that the FDA has accepted for review the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT). The company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT in March.
Grass pollen 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.
The BLA submission was based on Phase 3 trials which evaluated the safety and efficacy of the investigational product, including a long-term, multi-season trial.
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