FDA panel OKs Tresiba but raises red flag on heart safety
The advisory panel said more investigation is necessary, and voted 12-0 for a cardiovascular outcomes study. Leerink Swann analyst Seamus Fernandez wrote Wednesday that key opinion leaders “believe the best case scenario for degludec would be approval with a disadvantaged label citing potential CV safety risk with a post-approval CV outcomes study.” The advisory panel released its discussion materials before the Thursday meeting. Fernandez's KOLs also picked at Novo's hypoglycemia data, showing no advantage over Lantus and questionable overnight impact, “considering patients are less likely to check their blood glucose while sleeping, thereby making the data for nocturnal hypoglycemia less reliable.”
The FDA does not have to follow the advisory panel's advice, but Bernstein analyst Tim Anderson wrote Friday that Thursday's discussion hasn't persuaded him to change his forecast for Sanofi's Lantus. Anderson also noted that although Wednesday's discussion only affects the US market, higher domestic pricing makes the long-acting insulin market of particular note.
Novo spokesperson Ambre Morley told MM&M that there's no firm date for an FDA decision. The review date has already been pushed – Thursday's advisory committee meeting was after the scheduled PDUFA date. Morely said Novo “will continue our discussions with the FDA.”