FDA Approves Short Ragweed Pollen Allergen SL Tab
The FDA announced the approval of Ragwitek (Ambrosia artemisiifolia; Merck), the first sublingual allergen extract to treat short ragweed pollen induced allergic rhinitis, with or without conjunctivitis. Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen.
Ragwitek is approved for use in adults 18–65 years of age. It is designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect against targeted allergens.
The safety and effectiveness of Ragwitek was evaluated in approximately 1,700 adults. Of the 1,700 adults in the safety trial, about 760 were evaluated to determine effectiveness. Some patients received Ragwitek while others received placebo. The patients reported their symptoms and additional medications needed to get through the allergy season. During treatment for one ragweed pollen season, patients who received Ragwitek experienced about a 26% reduction in symptoms and the need for medications compared to those who received a placebo.
For more information call (800) 672-6372 or visit Merck.com.