Hits, Misses & Key Firsts For EMA’s PRIME Scheme
The rate at which investigational drugs were accepted onto the European Medicines Agency’s priority medicines scheme dropped in 2021. Meanwhile, more much-needed treatments that had been developed under the scheme went on to win EU marketing approval.
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This year’s first designations under the European Medicines Agency’s priority medicines scheme have gone to a maternal vaccine for an infection in newborns and a treatment for an ultra-rare bone disorder.
Not one of the applications reviewed by the European Medicines Agency this year for a place on its scheme for drugs for unmet medical needs has made the grade. Meanwhile, the agency recently explained how applicants could improve their chances of getting accepted on the initiative.
Nineteen new products that were developed under PRIME, the European Medicines Agency’s priority medicines scheme, are now approved for use in the EU. Pink Sheet analysis finds that many were reviewed much faster than they would have been under standard review timelines.