The US FDA has expanded the approval of Ragwitek (Short Ragweed Pollen Allergen Extract) tablet for sublingual use to treat short ragweed pollen-induced allergic rhinitis in patients aged five through 17, according to manufacturer ALK. Ragwitek was first launched for adult use in the US and Canada in 2014 and is now approved to treat patients aged 5 through 65.

Ragwitek is 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. The product is not indicated for the immediate relief of allergic symptoms, according to ALK.

Ragweed pollen is a common cause of seasonal airborne allergy in North America, causing allergic rhinitis and conjunctivitis. While regional variation exists, in many areas of the US, ragweed pollen season occurs from August to November and peaks in mid-September.

The approval was based, in part, on data from the largest Phase 3 clinical trial in children with ragweed allergic rhinitis, with or without conjunctivitis, conducted to date. The randomized, double-blind, parallel group, multicenter clinical trial evaluated the efficacy and safety of the drug in 1,022 children and adolescents ages five through 17 with a history of ragweed-induced rhinoconjunctivitis and sensitivity to short ragweed over an approximately 20-28 week treatment duration.

According to the company, treatment significantly improved symptoms in children and adolescents ages five through 17 and decreased symptom-relieving medication use compared to placebo. The safety profile in children and adolescents was consistent with the safety profile in adults, and overall, treatment was well tolerated and discontinuation rates due to adverse events were low.

“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 I. Bernstein, MD, FAAAAI, FACAAI, FACP, of University of Cincinnati College of Medicine. “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.” 

The full results were published in the peer-reviewed publication, The Journal of Allergy and Clinical Immunology.

“With the expanded approval of Ragwitek in the US, 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, President, ALK, Inc. “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.”