European regulators have rolled out a new scheme striving to accelerate the approval of promising new medicines through a programme of enhanced support for companies working on drugs targeting unmet medical needs.
The European Medicines Agency’s PRIME (PRIority MEdicines) initiative is similar to the ‘breakthrough’ status system used in the US, with both schemes aiming to speed up the evaluation of the most innovative therapies by offering early guidance on development programmes.
Through PRIME, the EMA said it will provide early, proactive and enhanced support to medicine developers to optimise the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of medicine applications. “This will help patients to benefit as early as possible from therapies that may significantly improve their quality of life,” it said.
The idea is to engage with medicine developers earlier to help strengthen clinical trial designs to facilitate the generation of high quality data for the evaluation of an application for marketing authorisation.
“We want to ensure that breakthroughs in medicines reach patients quicker,” says Dr Tomas Salmonson, chair of the Committee for Medicinal Products for Human Use (CHMP). “By strengthening collaboration between the scientific committees, and by gaining and sharing knowledge on the medicine throughout the development, we will not only accelerate patients’ access but also ensure an efficient use of available resources.”
“The launch of PRIME is a major step forward for patients and their families that have long been hoping for earlier access to safe treatments for their unmet medical needs, such as rare cancers, Alzheimer’s disease and other dementias,” noted Vytenis Andriukaitis, EU Commissioner for Health and Food Safety.
While PRIME is open to all companies on the basis of preliminary clinical evidence, micro-, small- and medium-sized enterprises (SMEs) and applicants from the academic sector are able to apply earlier on the basis of compelling non-clinical data and tolerability data from initial clinical trials.