FDA approves Ragwitek for treating Ragweed-induced Allergy - Merck

The FDA has approved Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use, from Merck, as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short Ragweed pollen. Ragwitek is approved for use in adults 18 through 65 years of age but is not indicated for the immediate relief of allergic symptoms.

The efficacy of Ragwitek was supported by two Phase III clinical studies over a single ragweed pollen season in patients 18 through 50 years of age. In these multi-center studies patients treated with Ragwitek had significant 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 peak ragweed pollen season, compared to placebo.