On April 17, 2014, the U.S. Food and Drug Administration (FDA) approved the drug Ragwitek to treat ragweed pollen-induced hay fever (allergic rhinitis) in adults. Ragweed pollen allergies are very common in Connecticut and can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes. Ragwitek was designed to decrease sensitivity to ragweed and lead to lasting relief from the symptoms of ragweed-induced hay fever. Treatment with Ragwitek is started 12 weeks before the start of ragweed pollen season and continued throughout the season. “The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease,” said Karen Midthun, M.D. of the FDA’s Center for Biologics Evaluation and Research.
The efficacy of Ragwitek in the treatment of ragweed pollen-induced hay fever was evaluated in two double-blind, placebo-controlled clinical trials in adults (18–50 years of age). Participants in the studies received Ragwitek or placebo for approximately 12 weeks prior to the start of the ragweed pollen season and throughout the ragweed pollen season. The participant population was 86% White, 9% African American, and 3% Asian and was almost equally divided between males and females. During treatment for one ragweed pollen season, participants who received Ragwitek experienced approximately a 26% reduction in symptoms and the need for medications compared to those who received a placebo.
Ragweed pollen is one of the most common seasonal allergens and is prevalent during the late summer and early fall months in most of the United States. Ragweed pollen-induced allergies are generally managed by avoiding the allergen, medications to relieve symptoms, or with immunotherapy (i.e., allergy shots). Ragwitek is a new immunotherapy; unlike allergy shots, it is administered as tablets under the tongue (sublingual). The tablets contain an extract from short ragweed (Ambrosia artemisiifolia) pollen, which is known to elicit allergic reactions in susceptible individuals. These sublingual tablets work by desensitizing the immune system to ragweed. The body responds to the allergen in the sublingual tablets (in this case, the extracts of ragweed pollen) by developing immunity or tolerance to the allergen.