Posted by Michael Wonder on 16 Dec 2016
SAGE-547 granted PRIME designation by EMA for the treatment of post-partum depression
16 November 2016 - New EMA regulatory designation offers potential for increased dialogue and accelerated assessment of future EU regulatory application.
Sage Therapeutics today announced that the EMA has granted its PRIority MEdicines (PRIME) designation to SAGE-547 for the treatment of post-partum depression (PPD). The 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 U.S. FDA granted SAGE-547 breakthrough therapy designation for the treatment of PPD.
