ALK Abello’s Acarizax for infants accepted for European review

The European regulatory filing for Acarizax (house dust mite sublingual immunotherapy tablet) in young children has been accepted for review by the relevant health authorities via a type II variation, the products marketer, Danish allergy immunotherapy company ALK Abello (ALK: DC), announced today.

The European Medicines Agency’s (EMA) regulatory review process is anticipated to take up to nine months so that, subject to approval, the first market introductions in Europe could take place from late 2024/beginning of 2025.

ALK’s executive vice president of research and development, Henriette Mersebach, says: “I’m pleased that our registration application for Acarizax for young children has been accepted for review, and we are looking very much forward to the dialogue with the European authorities over the coming months. The results in children are robust and consistent with previous trial results and this filing represents an important step forward for our ability to transform the medical treatment of children with house dust mite allergy as well as for ALK’s long-term growth ambitions.”