The number of investigational drugs that the European Medicines Agency accepted onto PRIME, its scheme for promising medicines for unmet medical needs, fell to a record low in 2022. Thirteen products secured a place on the program, compared with the all-time high of 20 in 2020.
Requests For EMA PRIME Designation Fall But Improvements Are On The Way
While the European Medicines Agency and industry speculate as to why 2022 saw far fewer applications for a place on the priority medicines scheme for drugs for unmet medical needs, they are enthusiastic about improvements to the initiative that are set to be trialed soon.

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Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.
The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.
A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.