The Food and Drug Administration has approved Ragwitek, a sublingual treatment for short ragweed pollen–related allergic rhinitis in people aged 18-65 years.
This is the first FDA-approved oral therapy for hay fever, with or without conjunctivitis, and the third oral allergy medication approved by the FDA in less than a month. On April 1, the agency green-lighted Oralair for the treatment of gross pollen-related allergies in persons aged 10-65 years. On April 15, Grastek earned approval as an oral treatment for grass pollen allergy in people aged 5-65 years.
The approval offers "millions of adults living with ragweed-pollen allergies in the United States an alternative to allergy shots to help manage their disease," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. Other treatments include avoiding the allergen and medications to treat symptoms.
Ragwitek contains traces of pollen from the short ragweed (Ambrosia artemisiifolia) plant, and is administered as a quick-dissolving tablet placed once daily under the tongue. Treatment begins 12 weeks before the ragweed pollen season begins in late summer/early fall, and continues throughout the season. The first dose of the therapy is taken under observation by a health care provider. If no adverse reaction is noted after 30 minutes, the patient self-administers the medication thereafter.
Ragwitek’s safety was assessed in approximately 1,700 adults. The most common adverse reactions included itching in the mouth and ears and some throat irritation. Among those patients, 760 were evaluated to determine the therapy’s efficacy. Those assigned to Ragwitek reported about a 26% reduction in symptoms, compared with those who took placebo.
A black box warning accompanies the treatment, cautioning that life-threatening, severe allergic reactions are possible. A self-injected dose of epinephrine is recommended if needed.
Catalent Pharma Solutions manufactures Ragwitek for Merck, Sharp & Dohme.
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