Merck has obtained approval from the US Food and Drug Administration (FDA) for its Grastek (Timothy grass pollen allergen extract) sublingual tablet as immunotherapy for treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis in children and adults.
Grastek has been developed for 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.
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The recommended dose of Grastek is one tablet per day. Grastek is not indicated for the immediate relief of allergic symptoms and the drug can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction.
According to the company, Grastek must be initiated at least 12 weeks before the expected onset of each grass pollen season and the treatment must be continued throughout the season. Safety and efficacy of in-season initiation have not been established.
Merck Research Laboratories Respiratory and Immunology vice-president Dr Sean Curtis said: “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.”
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By GlobalDataMerck expects to launch Grastek in the US market in towards the end of this month.
Grastek has demonstrated efficacy in two multi-centre, double-blind studies of approximately 24 weeks treatment duration over one grass season each in patients five through 65 years of age, and one five-year grass pollen season study in patients 18 through 65 years of age.
One study compared Grastek with placebo in 1,501 patients of ages five to 65 years. Approximately 25% of these patients had mild, intermittent asthma, while 85% of patients were sensitised to other allergens in addition to grass.
Compared with placebo, patients treated with Grastek have shown significant reduction of nasal and ocular symptoms, and reduction in use of symptom-relieving allergy medication, as measured by a decrease in the total combined scores (TCS) for the entire grass pollen season.
A second study compared Grastek with placebo in 344 patients of ages five to 17 years. Approximately 26% of these patients had mild, intermittent asthma, while 89% of patients were sensitised to other allergens in addition to grass.
Compared with placebo, patients treated with Grastek have shown reduction of nasal and ocular symptoms, and reduction in use of symptom-relieving allergy medication, as measured by a decrease in the TCS for the entire grass pollen season.
A five-year study compared Grastek with placebo in 634 patients of ages 18 to 65 years for three consecutive years and the patients were then observed for two years during which they did not receive study drug.
Patients treated with Grastek had a decrease in TCS throughout the grass pollen season during the three years of active treatment. This effect was sustained during the grass pollen season in the first year after discontinuation of Grastek, but not in the second year.
Image: Timothy grass is one of the most common grasses in the US. Photo: courtesy of Dartmouth Electron Microscope Facility.
