Novo Hemophilia Drug's Postmarket Monitoring Plan Not Robust Enough – US Panel
FDA advisory committee members support approval of investigational hemophilia B treatment nonacog beta pegol but say Novo Nordisk needs more systematic approach to monitoring for neurological and developmental adverse events.
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US FDA Sought Patient Viewpoint On Hemlibra's Benefit/Risk Profile
Hemophilia patient advocate expressed concerns to FDA about ability of hemophilia treatment centers to educate patients about thrombotic microangiopathy and thromboembolic events, unexpected but serious cases of which were seen in the clinical program.
Novo Nordisk Gets Approval For Hemophilia B Treatment Sans Postmarketing Requirements
Rebinyn's approval without postmarketing requirements comes as a surprise, given the advisory committee's concerns that the proposed plans weren't robust enough, as well as concerns from FDA about the treatment's safety.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.