ALK gains US pediatric approval for its ragweed SLIT-tablet

Shares of Danish allergy immunotherapy specialist ALK Abello (ALKB: DC) were up 2% at 2,502 Danish kroner this morning, after it announced that the US Food and Drug Administration has expanded the use of ALK’s ragweed sublingual allergy immunotherapy (SLIT) tablet Ragwitek (Ragwizax in Europe) to include pediatric patients, down to the age of five, with ragweed-induced allergic rhinitis.

Ragweed is a common cause of seasonal, airborne allergy in North America and in certain parts of Europe, as well as international markets. Ragwitek was first launched for adult use in the USA and Canada in 2014 and was approved in nine European countries and Russia in late 2017. In addition, ALK recently received European and Canadian regulatory approval for pediatric use of the ragweed tablet.

ALK’s executive vice president of R&D, Henrik Jacobi, says: “Ragweed is a major cause of allergy in North America. This expanded approval means there can now be an earlier intervention to treat what can be a distressing condition. It also advances ALK’s commitment to address unmet medical need by expanding the coverage of its tablet portfolio to cover patients of all relevant ages.”