Larimar Secures PRIME Designation In EU For Neurological Disease Drug
Support Scheme Accepts Potential Treatment For Friedreich’s Ataxia
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.
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Looking to develop the first drug therapy for FA, Larimar gets US FDA hold due to deaths in non-human primate study. This alters clinical development timelines and fundraising plans for the firm.
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.
The sponsor of what could become the EU’s first approved ophthalmic formulation of bevacizumab needs to address outstanding issues raised by the European Medicines Agency about its filing.