Odactra (Merck, Sharp & Dohme) had been approved in adults aged 18-65 years, with allergic rhinitis with or without conjunctivitis. The tablets offer an alternative to subcutaneous injections, the FDA said in aissued March 1.
The sublingual tablets are intended to be taken daily, year-round, and the first dose must be taken under physician supervision to monitor for adverse reactions, according to the FDA. As with other sublingual immunotherapies, patients using the tablets should be simultaneously prescribed autoinjectable epinephrine.
The approval was based on results from randomized trials enrolling about 2,500 patients in Europe and the United States, according to the FDA. Patients taking the tablets saw a 16%-18% reduction in symptoms across studies, compared with placebo. Clinical benefit may be delayed by 8-14 weeks after starting the therapy, the agency said. Common adverse reactions reported in the studies included nausea, itching of the ears and mouth, and swelling of the lips and tongue.
Odactra is the fourth sublingual immunotherapy to be approved in the United States since 2014. Other approved therapies target grass and ragweed allergies.