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Merck Announces FDA Acceptance of Biologics License Application for Immunotherapy Tablet

Published: Thursday, March 28, 2013
Last Updated: Thursday, March 28, 2013
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Merck 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 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.

“We are pleased to have achieved this important milestone in the development of our investigational grass pollen AIT, which, if approved, would represent a potential new option for allergy specialists to offer appropriate allergic rhinitis patients,” said Jeffrey A. Chodakewitz, M.D., senior vice president, Global Scientific Strategy, franchise head, Infectious Diseases and interim franchise head, Respiratory & Immunology, Merck Research Laboratories.

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.

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