Gene Therapy For Severe Retinitis Pigmentosa Secures EMA PRIME Status
Janssen and MeiraGTx say their investigational product is the only treatment for x-linked retinitis pigmentosa in development to win a place on the European Medicines Agency’s priority medicines scheme.
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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.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
Marketing applications for 10 new drugs have been added to the latest list of products under review by the European Medicines Agency.