Merck statement on FDA Advisory Committee meeting for RAGWITEK™, an investigational sublingual allergy immunotherapy tablet
Posted: 28 January 2014 |
Merck said it was pleased with the positive discussion of RAGWITEK™ at the Allergenic Products Advisory Committee meeting of the U.S. Food and Drug Administration…
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today said it was pleased with the positive discussion of RAGWITEK™ (Short Ragweed Pollen Allergen Extract) at the Allergenic Products Advisory Committee meeting of the U.S. Food and Drug Administration (FDA). RAGWITEK is the proposed trade name for the company’s investigational sublingual tablet for the treatment of diagnosed ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in appropriate adult patients who are candidates for immunotherapy.
“We appreciate the thoughtful discussion at today’s advisory committee meeting,” said Dr. Sean Curtis, vice president, Respiratory and Immunology, Merck Research Laboratories. “We believe RAGWITEK has the potential to be an important new oral therapeutic option for allergy specialists and their patients who continue to suffer from ragweed-induced allergic rhinitis.”
The FDA is not bound by the Committee’s guidance, but takes its advice into consideration when reviewing investigational medicines. The company expects the FDA’s review of RAGWITEK to be completed in the first half of 2014.
RAGWITEK is an immunotherapy designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect allergic patients against the effects triggered by ragweed pollen.
Merck has partnered with ALK-Abello to develop its investigational sublingual allergy immunotherapy tablets for Timothy grass pollen, ragweed pollen and house dust mite-induced allergic rhinitis in North America.
