News Report | May 28, 2019
FDA Grants Breakthrough Designation To Novel Schizophrenia Medication
On May 10, 2019, the U.S. Food and Drug Administration (FDA) granted "breakthrough therapy" designation to SEP-363856 for the treatment of schizophrenia. The designation makes SEP-363856 eligible for intensive guidance from the FDA on the drug development program and priority review. The manufacturers of the pharmaceutical agent are Sunovion Pharmaceuticals Inc. (Sunovion) and PsychoGenics Inc. (PsychoGenics).
FDA "breakthrough therapy" designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition. It can be granted when preliminary clinical evidence indicates that a drug demonstrates substantial improvement over available . . .