Merck MRK, known as MSD outside the United States and Canada, today
announced that the Biologics License Application (BLA) for its investigational
ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy
tablet has been accepted for review by the U.S. Food and Drug Administration
(FDA). On March 27, Merck 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 has a long history of developing new therapies to help patients with
allergic rhinitis,” said Jeffrey A. Chodakewitz, M.D., senior vice president,
interim franchise head, Respiratory & Immunology, Merck Research Laboratories.
“This regulatory milestone for our investigational ragweed pollen sublingual
allergy immunotherapy tablet represents another step in our continued
commitment to offering potential new options to allergy specialists and their
patients.”
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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