FDA Approves Treatment for Pollen-Induced Allergic Rhinitis in Children, Adolescents

The FDA has expanded its approval of short ragweed pollen allergen extract (Ragwitek; ALK) to include treatment for children and adolescents, starting at age 5 years, with short ragweed pollen-induced allergic rhinitis.

Officials with the FDA have approved short ragweed pollen allergen extract (Ragwitek; ALK) for the treatment of patients aged 5 to 65 years with short ragweed pollen-induced allergic rhinitis, according to the ALK, a seasonal allergy solutions company. According to ALK, short ragweed pollen allergen extract was first launched for adult use only in the United States in 2014.

Ragweed pollen is a common cause of seasonal allergies in North America, with ragweed pollen season occurring between August and November across the United States. According to ALK, ragweed pollen can cause allergic rhinitis and conjunctivitis, and the season typically peaks in mid-September.

Short ragweed pollen allergen extract is indicated as immunotherapy for the treatment of allergic rhinitis caused by short ragweed pollen, either with or without conjunctivitis and confirmed by a positive skin test or in vitro testing for pollen specific IgE antibodies. It is not indicated for the immediate release of allergic symptoms.

“[Short ragweed pollen allergen extract] 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, FAAAI, FACAAI, FACP, MD, of the University of Cincinnati College of Medicine, in a press release. “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.”

Allergy immunotherapy uses the patient’s own immune system to treat environmental allergies using small amounts of allergens. These allergens are introduced into the body so that the immune system can gradually learn to tolerate them. According to ALK, these treatments provide long-lasting improvements for years after treatment and are taken once-daily at home following the first dose administered in a physician’s office.

The FDA’s approval was partially based on data from the largest phase 3 clinical trial in children with ragweed allergic rhinitis, with or without conjunctivitis, conducted to date. The trial included 1022 children and adolescents ages 5 through 17 years with a history of ragweed-induced rhino-conjunctivitis and sensitivity to short ragweed over an approximately 20- to 28-week treatment duration.

According to ALK, treatment with short ragweed pollen allergen extract significantly improved symptoms in children and adolescents and decreased symptom-relieving medication use compared to the placebo. The safety profile in children and adolescents was similar to the safety profile in adults, and it was well-tolerated with low discontinuation rates due to adverse events.


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 [news release]. April 19, 2021; ALK. [email]