FDA Approves Timothy Grass Pollen SL Tab
Merck announced that the FDA has approved Grastek (Timothy grass pollen allergen extract) Tablet for Sublingual Use 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 patients 5–65 years of age. Grastek works by generating an immune response to help protect patients against Timothy grass pollen. Grass pollen-induced allergic rhinitis with or without conjunctivitis include symptoms such as sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes that usually intensify during the grass pollen season.
The efficacy of Grastek was supported by 2 studies of about 24 weeks treatment duration over one grass season each in patients 5–65 years of age, and one 5-year grass pollen season study in patients 18–65 years of age. Patients demonstrated significant reduction of nasal and ocular symptoms, and reduced use of symptom-relieving allergy medication vs. placebo.
Grastek will be available as a 2800 BAU (bioequivalent allergy units) strength in 3 blister packs of 10 tablets each. Grastek will be available in late April.
For more information call (877) 888-4231 or visit Merck.com.