The European Medicines Agency (EMA) has launched a new scheme, which it says will accelerate the development and review of new therapies for unmet medical needs.
The PRIME (Priority Medicines) programme has a lot of similarities with the US FDA’s breakthrough therapy designation, including greater cooperation between new drug developers and EMA’s scientific committees and accelerated assessment times.
EMA executive director Prof Guido Rasi said: “Our goal is to foster better planning of medicine development to help companies generate the high quality data we need to assess quality, safety and efficacy of medicines.”
The agency will provide advice on clinical trial designs and other scientific and regulatory considerations to help ensure that new drug sponsors file marketing applications that stand the best possible chance of approval. It first proposed the PRIME project last October.
“Patients with no or insufficient treatments could then benefit from scientific progress and cutting edge medicines as soon as possible,” added Rasi, who noted the EMA has also revised its guidance on accelerated assessment and conditional marketing authorisation in light of the PRIME launch.
The scheme aims to accelerate the development of new drugs to treat rare cancers, Alzheimer’s and other dementias and resistant infections, among others.
Moreover, the hope is that the scheme – which includes a provision to waive the EMA’s usual fees for scientific advice – could encourage more academic groups and small companies to propose candidates.
To be accepted into the PRIME programme a medicine has to have shown promise in early clinical trials, backed up by preclinical studies and experimental data from animal models.
If accepted, the sponsor is given a dedicated rapporteur from the EMA and a kick-off meeting of EMA experts is held to provide guidance on the development plan and regulatory strategy, with additional advice provided at key points as the programme progresses.
The main time-saving is expected to come from this process, as a more efficient and robust plan could carve months off the development process. Accelerated assessment can also trim a couple of months off the timeline.
Gauging the impact of PRIME is hard at the moment, but the FDA’s breakthrough programme can give some clues. It is notable that among the 44 new molecular entities (NMEs) approved for the first time last year, 31 were approved in the US first and eight (18%) had been given breakthrough status by the FDA.