CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SAGE-217 for development as a potential treatment for major depressive disorder (MDD). Fast Track is a process designed to facilitate the development and review of new treatments for serious conditions with unmet medical need such as MDD.
“The FDA Fast Track Designation is an important milestone in the development of SAGE-217, as it provides opportunities to potentially accelerate clinical development and future regulatory review of SAGE-217 for the treatment of MDD,” said Amy Schacterle, Ph.D., Senior Vice President, Regulatory Affairs and Quality Assurance of Sage. “Our discussions with regulatory agencies continue to focus on determining the most appropriate and efficient pathways for bringing new therapies to patients.”
About Fast Track Designation
Fast Track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. Drugs that receive Fast Track designation may be eligible to be the subject of more frequent communications and meetings with FDA to review the drug's development plan including the design of the proposed clinical trials, use of biomarkers and the extent of data needed for approval. Drugs with Fast Track Designation may also qualify for priority review to expedite the FDA review process, if relevant criteria are met.
The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. For more information about Fast Track, please visit:
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm.
About SAGE-217
Sage's most advanced, oral product candidate is SAGE-217, a novel, orally-active neuroactive steroid that is a positive allosteric modulator of synaptic and extrasynaptic GABAA receptors. The GABA system is the major inhibitory signaling pathway of the brain and CNS, and contributes significantly to regulating CNS function. SAGE-217 is currently in Phase 2 development in both mood and movement disorders, with four Phase 2 clinical programs now underway.
About Major Depressive Disorder
Major depression disorder (MDD) is a common but serious mood disorder in which patients exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and demonstrate impaired social, occupational, educational or other important functioning. Approximately 16 million people in the U.S. suffer from MDD each year.1 While antidepressants are widely used for treatment, large scale studies have demonstrated the need for additional therapies.2,3
About Sage Therapeutics
Sage Therapeutics is a clinical-stage biopharmaceutical company committed to developing novel medicines to transform the lives of patients with life-altering central nervous system (CNS) disorders. Sage has a portfolio of novel product candidates targeting critical CNS receptor systems, GABA and NMDA. Sage's lead program, brexanolone (SAGE-547), is in Phase 3 clinical development for super-refractory status epilepticus, a rare and severe seizure disorder, and for postpartum depression. Sage is developing its next generation modulators, including SAGE-217 and SAGE-718, in various CNS disorders. For more information, please visit www.sagerx.com.
