- The European Medicines Agency (EMA) grants Priority Medicines (PRIME) designation to Sage Therapeutics' (SAGE -1.6%) lead product candidate SAGE-547 for the treatment of postpartum depression (PPD).
- PRIME. launched by the EMA in March, is designed to aid and expedite the regulatory process for drugs that offer a significant therapeutic advantage over existing treatments or benefit patients who have no treatment options. It is akin to the FDA's Breakthrough Therapy designation.
- Once a drug has been selected for PRIME, the EMA appoints a rapporteur from the advisory committee CHMP or the Committee on Advanced Therapies (CAT) to assist the sponsor with building the knowledge that will support the marketing application, organizes a kick-off meeting with the rapporteur and a multidisciplinary group of experts with the aim of providing guidance on the overall drug development plan and regulatory strategy, assigns a dedicated contact person and provides scientific advice at key points in the development process.
- Phase 2-stage SAGE-547 is an allosteric modulator of both synaptic (junction between nerve cells) and extra-synaptic GABAa receptors. When activated, GABAa receptors cause the neuron to hyperpolarize which inhibits neurotransmission. It is also under development for the treatment of super-refractory status epilepticus.
- Previously: Sage Therapeutics' SAGE-547 a Breakthrough Therapy for postpartum depression (Sept. 6)
Original article