Winners And Losers: A Deep-Dive Into The EMA’s PRIME Scheme
Nine of the 70 medicines for unmet medical needs that have to date won a place on the European Medicines Agency’s PRIME scheme are now approved for sale in the EU, and two more approvals are expected soon. Meanwhile, most applications for a "priority medicine" designation are still missing the mark.
You may also be interested in...
The European Medicines Agency has accepted Larimar’s potential treatment for Friedreich’s ataxia onto its PRIME scheme for helping to get medicines for unmet medical needs to patients faster.
Last year saw the number of applications accepted onto the European Medicines Agency’s priority medicines scheme inch up and the notoriously high rejection rate for applications drop.
MYR’s Hepcludex obtained EU accelerated approval in July, making it the first approved therapy for hepatitis D. One analyst sees the drug as a blockbuster revenue opportunity for Gilead.