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FDA Approves Ragwitek for Short Ragweed Pollen Allergies

Patients take sublingual tablet once daily

The FDA has approved Ragwitek (Merck, Sharp & Dohme), the first allergen extract administered sublingually to treat short ragweed pollen-induced allergic rhinitis (hay fever), with or without conjunctivitis, in adults 18 through 65 years of age.

Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by placing it sublingually, where it rapidly dissolves.

Treatment with Ragwitek is initiated 12 weeks before the start of ragweed pollen season and is continued throughout the season. The first dose is taken in a health care professional’s office, where the patient is 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, MD, director of the FDA’s Center for Biologics Evaluation and Research.

Individuals with allergic rhinitis with or without conjunctivitis may experience a runny nose, repetitive sneezing, nasal itching, nasal congestion, and itchy, 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 U.S. Short ragweed pollen-induced allergies are generally managed by avoiding the allergen, by taking medications to relieve symptoms, or by taking allergy shots.

The safety and effectiveness of Ragwitek were evaluated in studies conducted in the U.S. and internationally. Safety was assessed in approximately 1,700 adults. The most commonly reported adverse reactions in patients treated with Ragwitek were itching in the mouth and ears, and throat irritation.

About 760 subjects were evaluated to determine the effectiveness of treatment. Some patients received Ragwitek; 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 approximately a 26% reduction in symptoms and the need for medications compared with patients who received placebo.

The prescribing information for Ragwitek includes a boxed warning to inform caregivers and patients that severe allergic reactions, some of which can be life-threatening, can occur. Ragwitek also has a medication guide for distribution to patients.

Source: FDA; April 17, 2014.

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