The approval expands the current sublingual tablet treatment indications to include children with a ragweed pollen allergy.
The US Food and Drug Administration (FDA) has approved short ragweed pollen allergen extract tablet (RAGWITEK) for the treatment of short ragweed pollen-induced allergic rhinitis in children and adolescents.
The approval, awarded to ALK, expands the RAGWITEK indication for the treatment of patients with ragweed pollen allergies between the age of 5 through 65 years old.
The tablet treatment is an allergen extract immunotherapy that provides treatment of patients with short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis.
Patients can take the once-daily sublingual tablets at home following a visit with an allergist. The product does not claim to result in the immediate relief of pollen allergy symptoms.
The approval is based on data from a phase 3 clinical trial in children with ragweed allergic rhinitis, without or without conjunctivitis. It is the largest trial conducted to date, based on children and adolescents aged 5-17.
The randomized, double-blind, parallel group, multi-center clinical trial assessed the efficacy and safety of the patient population over a 20-28-week treatment period. Patients had both a history of ragweed-induced rhinoconjunctivitis and sensitivity to short ragweed.
The results show that treatment with RAGWITEK had a significant improvement in symptoms in the patient population. It decreased other symptom-relieving medication use.
Safety profiles were consistent with adult use. and treatment resulted in consistent results with no adverse events. Treatment was tolerated by the patient group and there were low discontinuation rates due to adverse events.
In a statement accompanying the approval, Jorge Alderete, ALK President, expressed pride in the company's "innovative solutions" to patients including the millions who suffer from chronic allergies.
"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," Alderete said.