Allergic Rhinitis Rx in FDA Review Process

Merck issues statement on FDA Advisory Committee discussion on Grastek for allergic rhinitis

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today issued the following statement.

The statement came after the conclusion of the Allergenic Products Advisory Committee of the U.S. Food and Drug Administration (FDA) meeting to discuss GRASTEK® (Timothy grass pollen allergen extract). GRASTEK is the proposed trade name for the company’s investigational sublingual tablet for the treatment of Timothy grass induced allergic rhinitis, with or without conjunctivitis, in appropriate adult and pediatric patients who are candidates for immunotherapy.

“We are pleased with the positive discussion of GRASTEK at today's advisory committee meeting,” said Dr. Sean Curtis, vice president, Respiratory and Immunology, Merck Research Laboratories. “We believe GRASTEK has the potential to be an important new oral therapeutic option for allergy specialists and their patients who continue to suffer with Timothy grass pollen induced allergic rhinitis, and we look forward to continuing to work with the FDA as the agency completes its review of our biologics license application for GRASTEK.”

The FDA is not bound by the Committee’s guidance, but takes its advice into consideration when reviewing investigational medicines. Merck anticipates the FDA’s review of GRASTEK to be completed in the first half of 2014.

GRASTEK is designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect patients against Timothy grass 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.

Review Date: 
December 13, 2013