FDA Clears Sublingual Ragwitek for Ragweed Allergy

Megan Brooks

April 17, 2014

The US Food and Drug Administration (FDA) has approved Ragwitek (Merck Sharp & Dohme Corp), the first allergen extract administered under the tongue to treat short ragweed pollen–induced allergic rhinitis, with or without allergic rhinoconjunctivitis, in adults 18 through 65 years of age.

Allergic rhinitis affects 10% to 25% of the US population, and short ragweed pollen is one of the most common seasonal allergens to cause symptoms. It is most prevalent during the late summer and early fall months in most of the United States.

Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is placed under the tongue, where it dissolves in about 10 seconds. Once-daily treatment with Ragwitek is started 12 weeks before the start of ragweed pollen season and continued throughout the season, the FDA said.

The first dose is taken in a healthcare 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 FDA says.

"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," Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, said in a statement posted April 17 on the FDA's Web site.

The safety of Ragwitek was assessed in 1700 adults. The most commonly reported adverse reactions by patients treated with Ragwitek were itching in the mouth and ears and throat irritation.

Of the 1700 adults who participated in safety studies, about 760 were evaluated to determine effectiveness of Ragwitek against placebo. Over the course of a single ragweed pollen season, patients who received Ragwitek experienced about a 26% reduction in symptoms and the need for medications compared with those who received a placebo.

Prescribing Information for Ragwitek 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, the FDA said.

The FDA"s Allergenic Products advisory committee voted to recommend approval of Ragwitek earlier this year, as reported by Medscape Medical News.

Ragwitek is the third sublingual allergy immunotherapy approved by the FDA this year, the first being Oralair (Stallergenes Inc), and then Grastek (Merck & Co, Inc) just a few days ago., both reported by Medscape Medical News.


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