EMA PRIME Scheme: Two New Entries, 10 Rejections & One Withdrawal

A total of 141 products have made it onto the European Medicines Agency’s PRIME (priority medicines) scheme since 2016 and over 370 applications have been denied entry.

Modern Medical Research Laboratory: Portrait of Female Scientist Working on Computer, Analysing Biochemicals, Talking. Advanced Scientific Lab
The PRIME scheme is designed to help developers of medicines for unmet medical needs (Shutterstock)

NX-5948, Nurix Therapeutics’ treatment for relapsed or refractory chronic lymphocytic leukemia, and Ga68-PentixaFor, Pentixapharm’s radiodiagnostic for primary aldosteronism, are the latest investigational products to secure a place on PRIME, the European Medicines Agency’s priority medicines scheme for drugs addressing unmet medical needs.

Key Takeaways
  • NX-5948 and Ga68-PentixaFor are the latest entries on the PRIME scheme, bringing to 141 the total number of products to secure a place on the scheme.
  • Asunercept, Apogenix’s drug candidate for glioblastoma, has been withdrawn from the scheme due to poor trial results.
  • A total of 10 applications for a place on PRIME were denied in October and November, bringing to over 370 the number of applications that have so far been rejected

NX-5948 was among nine applications for a place on PRIME that the EMA’s human medicines committee, the CHMP, reviewed at its latest monthly meeting, which

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