FDA approves Merck's Ragwitek for short ragweed pollen allergies

The US Food and Drug Administration has approved US pharma giant Merck & Co’s (NYSE: MRK) Biological License Application for Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.

Licensed to Merck by Denmark’s ALK Abello (ALK: DC), 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 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, director of the FDA’s Center for Biologics Evaluation and Research.