- The European Medicines Agency (EMA) on Monday launched a new priority review program designed to increase regulatory support for promising drugs which provide a significant improvement over existing treatments.
- Dubbed "PRIME," or Priority Medicines, the framework will offer makers of potential breakthrough medicines continuous access to a dedicated EMA representative. The EU regulator hopes early collaboration with regulators will improve clinical trial designs and data.
- PRIME is designed to promote the existing accelerated assessment scheme, which cuts the review time for new drugs to 150 days or less (compared to the typical 210 days).
PRIME shares some similarities to the FDA's breakthrough designation process. Both programs aim to improve the speed at which promising and innovative drugs are approved for patient use.
In order to participate in PRIME, a drug must "offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options." While drugmakers currently can call on the EMA's accelerated assessment pathway to review such drugs, the agency noted an accelerated timetable is only confirmed several months prior to filing. Through PRIME, the EMA hopes to identify products meeting the accelerated assessment criteria more quickly, and provide better support as the products progress through development.
Since 2006, the EMA has evaluated 22 medicines under accelerated assessment.
“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,” said the EU Commissioner for Health and Food Safety, Vytenis Andriukaitis.
Andriukaitis also highlighted antibiotics as an area which could benefit from the program, particularly as antimicrobial resistance increases.
The EMA first mulled ways to improve the development of promising new drugs in December 2014. PRIME eventually evolved from those initial discussions.
The agency will review eligibility requests from drugmakers within 40 days through the Scientific Advice Working Party and the Committee for Medicinal Products for Human Use. Roughly 100 applications for PRIME are expected each year, according to Reuters.