We initially wrote about Sage here, SAGE-547 for Postpartum Depression. Today SAGE revealed through this press release Sage Therapeutics, the expedited pathway for drug SAGE-547 for Postpartum Depression. The important news was that the FDA in agreement with Sage, anticipates that no additional controlled studies will be necessary to file an NDA. The company believes that they may be able to file for a new drug application for Postpartum Depression in 2018. If approved by the end of 2019, the company will have patent until around 2034, or approximately 15 years of exclusivity. Below are the important aspects of the expedited pathway for SAGE-547, agreed upon by the FDA.
- Current SAGE-547 clinical studies confirmed as appropriate to support registration, if successful
- No additional efficacy studies expected to be required beyond those currently underway
- Trial design of studies 202B and 202C are considered appropriate for registration, with increase in size and other minor modifications
- The primary clinical endpoint for these pivotal trials was unchanged and agree upon with FDA
- Additional patient safety data may be acquired through an open-label program
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