25 June 2015
After the positive opinion issued by EMA/COMP for allopurinol 100 mg for the treatment of perinatal asphyxia, ACE received the final decision for the Orphan Drug Designation for allopurinol-sodium from the European Commission. The trademark name for the product is Allokid®. Allokid is included in the Community Register of Orphan Medicinal Products with number EU/3/15/1493.
Allokid is administered per i.v.-injection to the youngest children (immediately after birth). The significance is high: to prevent or at least limit brain damage from lack of oxygen during delivery of the baby.
The exciting registration process of orphan drugs with clinical studies, providing study medication, assessing data, and writing publications will be the next great adventure.
For this purpose ACE participates in the ALBINO-trial; an ambitious “Horizon 2020”-project. In the ALBINO-trial, children with asphyxia are treated with Allokid in addition to so called hypothermia –treatment (golden standard) following birth.
The treatment and its ethical aspects, the supply and distribution of study medication and the large number of participating centers make the study very complex. In a consortium of European academic centers, including the University Medical Center Utrecht (headed by Prof. Dr. Frank van Bel and Prof. Dr. Manon Benders), and a large number of community hospitals over 800 patients need to be recruited for this study. Overall coordination is in Tübingen, Germany, by Prof. Dr. Axel Franz (ERUT).
Allokid is a positive result of the cooperation between academy and industry.