EMA’s PRIME Enables Earlier Availability of Life-Changing Medicines

An EMA report, published on March 3, 2022, has analyzed the positive impact of the first five years of the Europe Medicines Agency’s (EMA’s) PRIority Medicines (PRIME) scheme. The PRIME scheme allows for the authorization of new medicines that are potentially life-changing for patients with unmet medical needs. Patients with little to no current treatment options were able to access new and emerging treatments at a faster rate, potentially improving their overall health.

EMA stated in a press release that the review of the PRIME scheme showed that, “From March 2016 to June 2021, a total of 18 medicines that had PRIME support were approved in the European Union (EU). Among these, 10 received a conditional marketing authorization (CMA) enabling them to access the market earlier and reach patients more quickly; seven are advanced therapy medicinal products (ATMPs), which have the potential to reshape the treatment of a wide range of conditions; and 16 concern rare diseases.”

PRIME medicines have allowed for faster patient access to innovative treatments for various unmet medical conditions, such as rare cancers and orphan diseases. Innovative technologies such as CAR T-cell therapies, one-time curative gene therapies, and new vaccines were also released faster as a result of the scheme. A total of 98 medicines have been accepted into the scheme as of the time of publication of the report.

Source: EMA