SAGE Therapeutics' (SAGE) SAGE-547 Receives EMA PRIME Designation

November 16, 2016 9:53 AM EST
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Sage Therapeutics (Nasdaq: SAGE) announced that the European Medicines Agency (EMA) has granted its PRIority MEdicines (PRIME) designation to SAGE-547 for the treatment of postpartum 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. Food and Drug Administration (FDA) 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.

"This priority medication designation for SAGE-547 within the EMA’s new PRIME program reflects the urgent need for treatment options for women suffering with postpartum depression and was supported by the promising clinical data from our Phase 2 study," said Jeff Jonas, M.D., Chief Executive Officer of Sage. “We look forward to working with the EMA to determine the appropriate regulatory path to support a European marketing authorization application for SAGE-547 in PPD as we initiate planning for our European operations and clinical trial infrastructure.”

Once an investigational candidate has been selected for PRIME, developers are assigned a dedicated contact point and a rapporteur from the Committee for Medicinal Products for Human Use (CHMP) to provide continuous support and help ahead of a marketing-authorization application, as well as a meeting with a multidisciplinary group of experts to provide broader guidance on the overall development plan and regulatory strategy. Companies are also eligible for accelerated assessment at the time of their regulatory application.

“We look forward to collaborating with the EMA on our EU regulatory strategy as we continue development of SAGE-547 as a potential treatment for postpartum depression,” said Amy Schacterle, Ph.D., Vice President, Regulatory Affairs and Quality Assurance of Sage. “We continue to work with regulatory agencies to determine the most appropriate and efficient pathways to bring potential new therapies to patients.”

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