IRLAB Therapeutics (STO:IRLAB-A; FRA:6IRA) has announced that the European Medicines Agency (EMA) has granted a waiver allowing the company to bypass pediatric studies of mesdopetam, enabling a focus on patient groups where Parkinson’s disease (PD) is more prevalent.
The company stated that the EMA’s Pediatric Committee (PDCO) recommended granting the waiver for all pediatric subsets. This decision exempts IRLAB from the obligation to conduct clinical studies of mesdopetam in children, which would have otherwise been required to secure a European marketing authorization for the treatment of PD.
Kristina Torfgård, CEO of IRLAB, commented, “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 FDA, the decision from EMA means that we can now focus our development efforts entirely on activities in more relevant patient groups,” Ms. Torfgård added.
