Merck Statement on FDA Advisory Committee for GRASTEK (Timothy Grass Pollen Allergen Extract)

Merck, known as MSD outside the US and Canada, has issued the following statement after the conclusion of the Allergenic Products Advisory Committee of the 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 FDA as the agency completes its review of our biologics licence application for GRASTEK.” 

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.