SAGE-547 granted PRIME designation by EMA for postpartum depression

The European Medicines Agencyhas granted its PRIority MEdicines (PRIME) designation to SAGE-547 for the treatment of postpartum depression (PPD).

US clinical-stage biopharma company Sage Therapeutics’ (Nasdaq: SAGE) SAGE-547 application for the PRIME designation was based on the positive clinical results from the placebo-controlled 202A study of SAGE-547 in severe PPD. In September, the US Food and Drug Administration granted SAGE-547 Breakthrough Therapy designation for the treatment of PPD.

The PRIME program was launched by the EMA in March 2016, and the designation is designed to aid and expedite the regulatory process for investigational medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options.To be accepted, an investigational medicine must show the potential to benefit patients with unmet medical needs based on early clinical data.