Cinclus Pharma has announced an agreement with the European Medicines Agency (EMA) on a pediatric study plan for linaprazan glurate. This agreement is a crucial step in securing marketing authorization for the drug in adult patients within the European Union. The planned pediatric study aims to assess the efficacy and safety of linaprazan glurate in children, potentially leading to an expanded indication for this patient population.
According to Cinclus Pharma, securing an agreed pediatric study plan is mandatory for obtaining marketing authorization in the EU for new medicines intended for adult patients. Christer Ahlberg, CEO of Cinclus Pharma, emphasized the importance of this milestone, stating, "It is extremely satisfying to have agreed on our pediatric study plan. It is a prerequisite for marketing authorization in the EU, so it is indeed a milestone. In addition, an approved pediatric indication would of course also significantly increase the target population for linaprazan glurate."
The pediatric efficacy and safety study is slated to commence following the submission of a marketing authorization application for linaprazan glurate. Further details regarding the study design, endpoints, and patient population were not disclosed in the announcement.
