ALK announced top-line results from a Phase III paediatric clinical trial of its sublingual allergy immunotherapy (SLIT) tablet for the treatment of ragweed-induced allergic rhinitis. The trial, which lasted three years and involved 1,022 participants in North America and Europe, was a Phase III, randomised, placebo-controlled trial to study the efficacy and safety of ALK's ragweed SLIT-tablet in children aged 5 to 17 with a history of ragweed-induced allergic rhinitis (also known as hay fever). The trial was conducted by MSD (known as Merck in the USA and Canada), under the terms of its former partnership agreement with ALK. The trial was designed to assess whether treatment with SLIT-tablets would result in a significant reduction in symptoms and medicine use during the peak ragweed season. The primary endpoint was a reduced total combined score (TCS) covering symptoms and medication use. The trial achieved its primary endpoint with a TCS reduction of 38% compared to placebo treated patients, which was highly statistically significant (p<0.001), with a lower bound of the 95%-confidence interval of 30%, versus a threshold of 10% as required by the US Food and Drug Administration. The trial also demonstrated that the treatment was well tolerated and had a favourable safety profile. Moreover, the findings of clinically relevant efficacy in children are consistent with what has previously been demonstrated for its sister product, GRAZAX for grass pollen allergies. ALK will now begin dialogue with relevant regulatory authorities about extending the current product labelling. Furthermore, ALK expects to present the further details from the trial at a scientific congress later in 2019. Ragweed is a common cause of seasonal, airborne allergy in North America and in certain parts of Europe as well as international markets. AGWITEKTM 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.