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The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.
The European Medicines Agency (EMA) announced on March 7, 2016 the launch of the PRIority MEdicines (PRIME) scheme, which was created to strengthen the agency’s support of drugs that treat unmet medical needs. The scheme, which focuses on drugs that may offer new treatments or advantages over existing treatments, offers enhanced early support to drug developers to optimize data generation and enable accelerated assessment of drug approval applications. This early involvement aims to strengthen clinical trial designs to generate high-quality data for market authorization applications.
“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,” explains Professor Guido Rasi, EMA’s executive director. “Patients with no or insufficient treatments could then benefit from scientific progress and cutting edge medicines as soon as possible.”
To be considered for prime, a drug must demonstrate a potential benefit to patients with unmet needs based on early clinical data. After acceptance into the scheme, EMA will appoint a rapporteur from EMA’s Committee for Medicinal Products for Human Use (CHMP) or from the Committee on Advanced Therapies (CAT) in the case of an advanced therapy, to provide continuous support and help to build knowledge ahead of a marketing authorization application. EMA will organize a kick-off meeting with the CHMP/CAT rapporteur and a multidisciplinary group of experts from relevant EMA scientific committees and working parties. EMA will also provide guidance on the overall development plan and regulatory strategy.
The candidate drug also is assigned a dedicated EMA contact point. The agency will provide scientific advice at key development milestones, involving additional stakeholders, such as health technology assessment bodies, to facilitate patients’ quicker access to the new medicine.
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 can apply early on the basis of “compelling non-clinical data and tolerability data from initial clinical trials.”
EMA states that, “although PRIME is specifically designed to promote accelerated assessment, it will also help to make best use of other EU early access tools and initiatives, which can be combined whenever a medicine fulfills the respective criteria.”
“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,” says Vytenis Andriukaitis, EU commissioner for health and food safety. “Through enhanced scientific support this scheme could also help, for example, to accelerate the development and authorization of new classes of antibiotics or their alternatives in an era of increasing antimicrobial resistance.”
“We want to ensure that breakthroughs in medicines reach patients quicker,” says Dr Tomas Salmonson, chair of the 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.”
Guidance documents on PRIME and additional tools have been published by EMA. Revised guidelines on the implementation of accelerated assessment and conditional marketing authorization were also published.