FDA expands approval of Ragwitek for young people age 5 and above in ragweed pollen-induced allergic rhinitis.- ALK Abello

ALK Abello announced that the FDA approved Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use for the treatment of short ragweed pollen-induced allergic rhinitis in persons ages five through 65. Ragwitek was first launched for adult use in the U.S. and Canada in 2014 and was approved in nine European countries and Russia in late 2017.The approval was based, in part, on data from the largest Phase III 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 Ragwitek 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. Treatment with Ragwitek 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. The full results were published in the peer-reviewed publication, The Journal of Allergy and Clinical Immunology.