The FDA approved Merck’s Grastek tablet to treat grass pollen-induced allergic rhinitis with or without conjunctivitis in people aged 5 through 65 years, making it the second sublingual oral immunotherapy (SLIT) agent approved for this use.
The agency approved another multi-grass pollen SLIT agent, Oralair, earlier this month. Oralair is the first FDA-sanctioned alternative to subcutaneous injections; however, it’s approval only extends down to children aged 10 years.
Grastek contains a single pollen-specific IgE antibodies for Timothy grass, but the pollen is cross-reactive with multiple other grass species, including sweet vernal, orchard, perennial rye, Kentucky blue , meadow fescue and redtop, the drug maker noted in a press release.
Like Oralair, the first dose of Grastek should be administered in a healthcare provider’s office under the supervision of a clinician experienced with diagnosing and treating allergies.
Although the timing of grass pollen season varies regionally across the United States, Grastek treatment should begin at least 12 weeks before the expected start of the grass pollen season and continue throughout.
Grastek is not indicated for patients with severe, unstable or uncontrolled asthma, or for those with a history of any severe systemic allergic reaction, a history of severe local reaction after taking sublingual allergen immunotherapy or a history of eosinophilic esophagitis.
The medication is expected to available in U.S. pharmacies in late April.