14/02/2025
Mikrobiomik has reached a new milestone upon receiving the approval of the Paediatric Investigation Plan (PIP) from the European Medicines Agency (EMA) for the treatment of Clostridioides difficile infection (CDI) in paediatric patients.
This approval represents a fundamental step in the regulatory process that we have initiated with the aim of bringing our investigational medicine MBK-01 to market.
The PIP is a regulatory requirement in the European Union designed to ensure that medicines under development are evaluated in the paediatric population, as long as it is scientifically viable and clinically relevant.
Following evaluation by the EMA Paediatric Committee, a PIP for the treatment of primary refractory and recurrent Clostridioides difficile infection in a group of patients aged between one and 18 years has been approved. The plan establishes the supply of MBK-01 in a gastro-resistant capsule pharmaceutical form suitable for administration to this population.
As part of the official statement, a postponement has been granted in the execution of the PIP, allowing the paediatric trial to be carried out at an appropriate time within the drug development process. Likewise, a waiver has been granted for the subgroup of paediatric patients under one year of age, for whom the drug does not provide a significant therapeutic benefit over existing treatments.
The EMA’s validation of the PIP supports the scientific robustness of the development of MBK-01 and allows progress in its regulatory process, paving the way for its future approval and market access.
The approval of this plan represents a milestone on the road to the availability of innovative treatments, and Mikrobiomik continues to consolidate its leadership in the field of gut microbiota-based drugs.
