FDA Accepts BLA for Merck's Allergy Immunotherapy Tablet - - BioPharm International

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FDA Accepts BLA for Merck's Allergy Immunotherapy Tablet


Merck announced in a press statement that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet. On March 27, the company announced that the 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's ragweed pollen sublingual allergy 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 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.

 

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