Merck Announces FDA Acceptance of Biologics License Application for Investigational Ragweed Pollen Sublingual Allergy Immunotherapy Tablet
May 8, 2013 7:30 am ET
Merck (NYSE: 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.
About Merck
Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
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Securities Litigation Reform Act of 1995. These statements are based
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by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
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for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.
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found in Merck’s 2012 Annual Report on Form 10-K and the company’s other
filings with the Securities and Exchange Commission (SEC) available at
the SEC’s Internet site (www.sec.gov).
Merck
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