Does ragweed make you miserable? Help is on the way.
The U.S. Food and Drug Administration has approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever) in adults 18 years through 65 years of age.
Ragwitek, which contains an extract from short ragweed (Ambrosia artemisiifolia) pollen, is a tablet that is taken once daily by placing it sublingually, where it rapidly dissolves. Treatment with Ragwitek is started 12 weeks before the start of ragweed pollen season and continued throughout the season.
The first dose is taken in a health care professional’s office where the patient is to be observed for at least 30 minutes for potential adverse reactions. After the first dose, patients can take Ragwitek at home.
“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., director of the FDA’s Center for Biologics Evaluation and Research.
A common ailment
Individuals with allergic rhinitis with or without conjunctivitis may experience a runny nose, repetitive sneezing, nasal itching, nasal congestion, and itchy and watery eyes. Short 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. Allergies induced by short ragweed pollen are generally managed by avoiding the allergen, medications to relieve symptoms, or with allergy shots.
The safety of Ragwitek was assessed in approximately 1,700 adults. The most commonly reported adverse reactions by patients treated with Ragwitek were itching in the mouth and ears and throat irritation.
Of the 1,700 adults, about 760 were evaluated to determine effectiveness. Some patients received Ragwitek; others received an inactive substitute (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 approximately a 26% reduction in symptoms and the need for medications compared with those who received a placebo.
The Prescribing Information includes a boxed warning to inform that severe allergic reactions, some of which can be life-threatening, can occur. Ragwitek also has a Medication Guide for distribution to the patient.