The Food and Drug Administration (FDA) has expanded the approval of Ragwitek® (short ragweed pollen allergen extract) to include patients 5 to 17 years of age for the treatment of short ragweed pollen-induced allergic rhinitis. Previously, the treatment was only indicated for adults 18 to 65 years of age.
The approval was based on data from a multicenter, double-blind, placebo-controlled phase 3 trial (ClinicalTrials.gov: NCT02478398) that assessed the efficacy and safety of Ragwitek in 1022 patients 5 to 17 years of age with a history of ragweed-induced rhinoconjunctivitis and sensitivity to short ragweed with or without asthma. Patients were randomly assigned 1:1 to receive Ragwitek or placebo 12-20 weeks before the start of the ragweed pollen season and throughout the ragweed pollen season. The primary endpoint was the average total combined score (TCS), defined as the sum of rhinoconjunctivitis daily symptom score (DSS) and daily medication score (DMS), during peak ragweed pollen season.
Results showed a decrease in TCS during the peak ragweed season for patients treated with Ragwitek compared with those who received placebo (difference relative to placebo: -38% [95 CI, -46.0, -29.7]). Additionally, a decrease in average TCS from the start of and throughout the entire ragweed pollen season was observed in Ragwitek-treated patients compared with placebo (difference relative to placebo: -32% [95% CI, -40.7, -23.2]). Similar decreases were observed across other endpoints including DSS and DMS peak season scores.
The safety profile of Ragwitek in patients 5 to 17 years of age was consistent with that previously observed in adult studies. Ragwitek was well tolerated with low discontinuation rates. There were no reported events of anaphylaxis, airway compromise, or severe treatment-related systemic allergic reactions.
“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.
Ragwitek is available as a sublingual tablet in 30- and 90-count blister packages.
- U.S. FDA approves ALK’s Ragwitek® (short ragweed pollen allergen extract) Tablet for sublingual use as immunotherapy for children and adolescents with short ragweed pollen-induced allergic rhinitis with or without conjunctivitis. [press release]. Round Rock, TX: ALK; April 19, 2021.
- Ragwitek® [prescribing information]. Round Rock, TX: ALK. 2021.
This article originally appeared on MPR