HealthDay News — The FDA has approved the oral tablet Ragwitek to treat short ragweed pollen-induced allergic rhinitis among adults aged 18 to 65 years.
The therapy is indicated for patients whose allergy has been confirmed by a positive skin test or in vitro testing for pollen-specific immunoglobulin-E antibodies and for patients with and without conjunctivitis.
The once-daily tablet contains an extract from short ragweed Ambrosia artemisiifolia pollen, the agency said in a news release. Treatment should begin 12 weeks before the start of ragweed season — which in the United States includes late summer and early fall — and continues through the season.
The product is placed under the tongue, where it rapidly dissolves. The first dose should be given administered by a healthcare provider, who should then monitor the patient for 30 minutes for any adverse reactions, the FDA said in a press release. Subsequent doses can be taken at home.
Ragwitek’s safety and effectiveness were evaluated in clinical studies involving some 1,700 adults. The most common side effects included throat irritation and itching of the mouth and ears.
The product’s label will include a boxed warning that it could cause a life-threatening reaction among people who are severely allergic to the pollen of short ragweed, one of the most common seasonal allergens. Patients prescribed Ragwitek should also be prescribed auto-injectable epinephrine and trained in its use.
The medication is contraindicated in patients with severe, unstable or uncontrolled asthma or a history of any severe systemic allergic reaction, eosinophilic esophagitis or any severe local reaction after taking any SLIT agent.
Ragwitek is produced for New Jersey-based Merck and Co. by Catalent Pharma Solutions, based in the United Kingdom. The drug is expected to be commercially available by the end of April.