FDA approves new indication for ALK's Ragwitek

ALK has received the Food and Drug Administration’s clearance for a new indication for Ragwitek (short ragweed pollen extract tablet for sublingual use) for the treatment of short ragweed pollen-induced allergic rhinitis in patients 5-65 years old. Ragwitek was first launched for adult use in the U.S. in 2014.

The product an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen.

"With the expanded approval of Ragwitek in the United States, we can now offer a treatment option for children, adolescent and adult patients across North America with seasonal ragweed pollen allergies and allergic rhinitis who continue to be burdened by symptoms despite available treatments," said Jorge Alderete, ALK president. "At ALK, we are proud to provide innovative solutions, including RAGWITEK, to the millions of people who suffer from chronic allergies and build on our SLIT-tablet portfolio of treatments for patients."

"Ragwitek tablets provide a new sublingual, or under-the-tongue, allergy immunotherapy treatment option for children and adolescents with seasonal ragweed allergies which often causes uncomfortable nasal symptoms and red, itchy eyes during the late summer and early fall," said David Bernstein, of the University of Cincinnati College of Medicine, Bernstein Clinical Research. "Sublingual immunotherapy targets the specific allergy trigger, in this case ragweed pollen, and reduces ragweed allergy symptoms by stimulating the immune system, helping patients achieve symptom relief through the ragweed season with an option that can be taken at home following an initial visit with an allergist."