IRLAB has received a waiver from the EMA regarding pediatric studies with mesdopetam in Parkinson’s Disease

EMA’s Paediatric Committee (“PDCO”) recommended, and EMA has granted, a waiver for mesdopetam for all pediatric subsets of the pediatric population to treat Parkinson’s disease. This waiver frees IRLAB from the obligation to conduct clinical studies of mesdopetam in children, which would otherwise have been mandatory to support a European marketing authorization application for the treatment of Parkinson’s disease.

“We are pleased that EMA has confirmed that pediatric studies evaluating mesdopetam are not needed to support a market authorization application for Parkinson’s disease.
Since we have previously received a corresponding decision from the US Food and Drug Administration (FDA), the decision from EMA means that we can now focus our development efforts entirely on activities in more relevant patient groups,” says Kristina Torfgård, CEO of IRLAB.

In 2007, the European Union introduced the Paediatric Regulation, transforming the development of medicines for children. A fundamental principle is that pharmaceutical development companies need to submit pediatric investigation plans for all new drugs. A key component of this initiative was the establishment of the PDCO, which coordinates EMA's pediatric medicine efforts and specifies required studies for companies. In certain cases, the PDCO may recommend a waiver for a Pediatric Investigation Plan when developing a medicine for children is not feasible or appropriate.