Moderna & Merck’s mRNA Cancer Vaccine Secures EMA PRIME Designation
A total of four investigational products targeting unmet medical needs have made it onto the European Medicines Agency’s priority medicines scheme so far this year.
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Promising early clinical trial results from Rocket and Abbisko respectively helped the companies secure their places on the European Medicines Agency’s priority medicines scheme, which aims to help speed up the development and regulatory review of treatments for unmet medical needs.
The partners unveiled long-awaited proof-of-concept data for mRNA-4157 at the AACR meeting showing a statistically significant improvement in recurrence-free survival among melanoma patients.
The European Medicines Agency will hold submission readiness meetings with the sponsors of products in the priority medicines scheme around a year ahead of them submitting their marketing authorization applications for regulatory review.