Giovanni Zampano -

On 1st June 2016 the European Medicines Agency (EMA) released the outcome of the assessment of the first group of applications for its PRIME (PRIority MEdicines) scheme, a new initiative to enhance support for the development of medicines that have the potential to address unmet medical needs.

 

18 applications for PRIME were received as of 6th April 2016 and subsequently assessed by EMA. 4 medicines have been accepted for PRIME. EMA is making available detailed information on the applications that have been granted or denied access to PRIME, including statistics on the type of applicants, the therapeutic areas represented and the data supporting the applications. The names of the four active substances that will benefit from PRIME support are also released.

 

Since 6th April 2016, another 14 applications have been submitted and, going forward, the Agency will release information on PRIME on a monthly basis, on the Wednesday following the plenary meeting of the CHMP.

EMA launched PRIME (PRIority MEdicines) on 7th March 2016. The scheme is built on the existing legal and regulatory framework, so as tools already available such as scientific advice, accelerated assessment and conditional approval.

 

Through PRIME, the Agency offers early dialogue, interaction and proactive support to medicine developers to optimize the generation of robust data on a medicine’s benefits and risks and so to speed up evaluation and availability for the patients of therapies that may significantly improve their quality of life.

 

Key benefits for applicants are:

  • early appointment of Rapporteur from the Committee for Medicinal Products for Human Use (CHMP) or from the Committee on Advanced Therapies (CAT) in the case of an advanced therapy;
  • kick-off meeting with the CHMP/CAT Rapporteur and a multidisciplinary group of experts;
  • assignment of a dedicated EMA contact point;
  • scientific advice at key development milestones, involving additional stakeholders such as health-technology-assessment (HTA) bodies;
  • confirm potential for accelerated assessment at the time of an application for marketing authorization (in principle, developers of a medicine that benefitted from PRIME can expect to be eligible for accelerated assessment at the time of application for a marketing authorization).

 

In order to be eligible and accepted for PRIME scheme, a medicine has to show its potential to benefit patients with unmet medical needs, based on early clinical data.

 

Particular interest is shown for SMEs and academia, which generally have less experience with the regulatory framework and therefore would benefit from earlier scientific and regulatory advice. In fact, while PRIME is open to all companies on the basis of preliminary clinical evidence, applicants from the academic sector and micro-, small- and medium-sized enterprises (SMEs) can apply earlier on the basis of compelling non-clinical data and tolerability data from initial clinical trials. They may also request fee waivers for scientific advice.

 

EMA PRIME scheme comes after the U.S.’s Breakthrough Therapy and Japan’s SAKIGAKE processes also attempting to speed access to new medicines.

 

By encouraging dialogue with regulators earlier in the development process, PRIME allows for extended consideration of a potential product’s efficacy and safety profile and seeks to address the bottlenecks of the regulatory framework that currently impact medicines development and access.

 

According to the most recent discussions on PRIME scheme, including EFPIA comments, it seems that one of the key issues to be addressed in order for PRIME to be a success is the involvement of HTA bodies early in PRIME discussions to help avoid delays in reimbursement and pricing decisions after regulatory approval. This is crucial to actually bring new treatments to patients sooner.

Comments are closed for this post.