
FDA Accepts BLA for Merck's Allergy Immunotherapy Tablet
The FDA has accepted for review Merck's Biologics License Application for its investigational ragweed pollen sublingual allergy immunotherapy tablet.
Merck announced
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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