EMA has presented the results from the first two years of PRIME. The main objective of PRIority Medicines scheme (PRIME) is to support and optimize medicine development, in therapeutic areas with the most pressing unmet medical needs, allowing patients to have access to new treatments.
Of all the requests, 36 (21%) have been accepted. The overview of the accepted medicines shows the focus on therapeutic areas where the availability of new medicines could be particularly beneficial such us rare diseases, paediatric diseases and oncology. In addition, it’s also relevant that 40% of the admitted medicines are advanced therapy medicinal products (ATMPs).
Since launch of the scheme, a total of 37 scientific advice requests have been received concerning 22 products accepted into PRIME.
After two years, there are three marketing authorization applications for medicines that were accepted for PRIME that are currently are under evaluation for the EMA.
If you think your project development can fit the PRIME scope, Asphalion can support you during all the procedure. Contact us at [email protected]
