Moberg Pharma receives approval from the EMA’s Paediatric Committee
Moberg Pharma AB (OMX: MOB) today announces that it has received approval of the pediatric plan for MOB-015 from EMA’s paediatric committee (PDCO). This approval enables the company to pursue a full marketing authorization application providing up to ten years of exclusivity in Europe following approval. The company´s timeline remains, with planned submission for MOB-015 in Europe this year and expected market approval in 2023.
Today´s positive decision means that Moberg Pharma will conduct a pediatric study during and after the approval process for MOB-015. The study includes 30 children, 6 to 17 years of age, and will be initiated in the second half of 2022. The pediatric study supplements the already completed clinical program, including the two phase 3 studies with a total of more than 800 patients, where the primary endpoint was achieved in both the North American and European studies.
“The approval enables data exclusivity in Europe for up to 10 years and further strengthens our intellectual property protection of MOB-015. It is an important milestone towards our goal to submit a registration application for MOB-015 in Europe this year,” says Anna Ljung, CEO of Moberg Pharma AB.