Supplier News Breaks Archives
Merck cleared to market grass allergy treatment
April 14th, 2014
WHITEHOUSE STATION, N.J. – Merck has received approval from the Food and Drug Administration for Grastek, a sublingual tablet for the treatment of grass allergies.
The company said late Monday that Grastek is an allergen extract (Timothy Grass Pollen 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.
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.
Approved for people ages 5 through 65, Grastek is slated to be available in U.S. pharmacies in late April.
The recommended dose of Grastek is one tablet daily to be placed under the tongue, where it will dissolve. Users are recommended to begin taking the medication at least 12 weeks before the expected onset of each grass pollen season and continue treatment throughout the 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," stated 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."
Timothy grass is one of the most common grasses in the United States and has been demonstrated to be cross-reactive with other grasses, including sweet vernal, orchard (also known as cocksfoot), perennial rye, Kentucky blue (also known as June grass), meadow fescue and redtop, according to Merck.
It is estimated that about 7.5 million U.S. 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.
The prescribing information for Grastek includes a boxed warning regarding severe allergic reactions. Grastek 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.