Merck Receives FDA Approval For Allergy Immunotherapy Grastek

Merck announced that it has received the approval of U.S. Food and Drug Administration (FDA) for Grastek (Timothy Grass Pollen Allergen Extract) tablet for sublingual use. The company said Grastek will be commercially available in U.S. pharmacies in late April this year.

Timothy grass is among the most common grasses in the U.S. and has been demonstrated to be cross-reactive with other common grasses including orchard, sweet vernal, Kentucky blue, and perennial rye. An estimated 7.5 million patients (children and adults ages 5 to 64) have been diagnosed with moderate to severe allergic rhinitis, and are sensitized to Timothy and cross-reactive grass pollens.

“Every grass pollen season, many patients with moderate to severe allergic rhinitis experience nasal and ocular allergy symptoms at their worst while taking symptom-relieving medication. These patients often have multiple sensitivities. Some of these patients may be candidates for immunotherapy, but decline allergy shots. With the FDA approval of Grastek, allergy specialists now have a new sublingual approach to offer these patients for their grass allergies,” said Dr. David Bernstein, professor of medicine and environmental health of Division of Immunology, Allergy and Rheumatology, at the University of Cincinnati College of Medicine.

Grastek is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. The immunotherapy is not indicated for the immediate relief of allergic symptoms.

The approval of Grastek was based on the efficacy results from two multi-center studies demonstrating that the drug significantly reduced nasal and ocular symptoms compared to placebo.

Dr. Sean Curtis, vice president of Respiratory and Immunology at Merck Research Laboratories, said, “The FDA approval of Grastek brings an important new sublingual tablet for allergy specialists treating adults and children with allergic rhinitis with or without conjunctivitis caused by Timothy or cross-reactive grass pollens. This important milestone marks another opportunity for Merck to build on our respiratory heritage with allergy specialists.”