Merck announced that the U.S. Food and Drug Administration (FDA) has approved Grastek (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use [2800 Bioequivalent Allergy Units (BAU)]. Grastek is an allergen extract 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. Grastek is approved for use in persons 5 through 65 years of age. Grastek is not indicated for the immediate relief of allergic symptoms.
The prescribing information for Grastek includes a boxed warning regarding severe allergic reactions. Grastek is contraindicated in patients with severe, unstable or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.
“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,” said Dr. David Bernstein, professor of medicine and environmental health, Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine. “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.”
Symptoms of grass pollen-induced allergic rhinitis with or without conjunctivitis may include sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes, and typically intensify during the grass pollen season.
“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,” said Dr. Sean Curtis, vice president, Respiratory and Immunology, Merck Research Laboratories. “This important milestone marks another opportunity for Merck to build on our respiratory heritage with allergy specialists.”
Date: April 14, 2014