US FDA Panel Says Covis’ Makena Should Be Withdrawn – And This Time It Wasn’t Close
Fourteen of 15 advisory committee members said the preterm birth prevention drug should come off the market while a new study is conducted; panelists cited concerns about allowing continued marketing when efficacy has not been demonstrated, and they rejected Covis’ assertion that it would be harder to recruit a new study if Makena were pulled.
You may also be interested in...
Intarcia Gets Its Hearing: FDA Panel To Weigh Nonapproval Of Diabetes Drug/Device Combo In September
Since the Center for Drug Evaluation and Research is conducting the single-day hearing on the type 2 diabetes treatment ITCA 650 under its usual process for advisory committee meetings, it denied Intarcia’s requests for input on adding ad hoc members and extended presentation time.
Supplemental Filings: Back To US FDA’s Conference Center, What Marks Wants In A Gene Therapy Director, And More
Short stories about how US FDA’s conference center changed since COVID-19 forced the end of in-person public events, what the agency did to officially close the books on Makena, and more.
Seeking to reverse CDER’s proposal to reject the NDA, Intarcia wants a say in formulating issues to be presented to the committee and questions inclusion of device experts as ad hoc members that will consider the fate of ITCA 650, a subdermal pump which delivers the GLP-1 agonist exenatide.