ALK-Abelló A/S plans to seek an expanded use of its allergy medicine Ragwitek in children after the drug helped reduce symptoms of an allergic condition in a late-stage study.
The Denmark-based pharmaceutical company said the three-year phase 3 trial — conducted by Kenilworth, N.J.-based Merck & Co. Inc. under a former agreement with ALK-Abelló — evaluated Ragwitek against placebo in 1,022 children in North America and Europe between the ages of five and 17 who had a history of ragweed-induced allergic rhinitis.
Allergic rhinitis, also known as hay fever, is a type of inflammation in the nose that occurs when the immune system overreacts to allergens in the air — in this case, caused by pollen released from the ragweed plants. Symptoms of the condition include a runny or blocked nose, itchy eyes, and sneezing.
Ragweed is a common cause of seasonal, airborne allergies in North America and in certain parts of Europe and international markets, according to a Jan. 15 news release.
ALK-Abelló's Ragwitek, an allergy immunotherapy tablet, is an alternative way to treat allergies without injections where a patient gets small doses of an allergen under the tongue to boost tolerance to the substance and reduce symptoms.
The trial showed that Ragwitek reduced symptoms of the condition by 38% compared to patients on placebo. The treatment was also well-tolerated and had a favorable safety profile.
ALK-Abelló said the trial's efficacy data for children was consistent with its other drug Grazax for treating grass pollen allergies. The company said it will release further data from the trial at a scientific congress later in the year.
The company will begin discussions with regulatory authorities about extending the product labeling for Ragwitek, which 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.