FDA panel OKs Tresiba but raises red flag on heart safety

Share this article:
An FDA advisory panel's 8-4 endorsement of Novo Nordisk's experimental insulin Tresiba (degludec) has not been encouraging for analysts, who find concern in the panel's discussion regarding heart health. The advisory panel's discussion documents note that although diabetes patients have an inherent risk of heart disease, meta analysis showed that Novo's candidate conferred an “increased risk of cardiovascular death, non-fatal MI, non-fatal stroke and unstable angina relative to comparators.”

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.”
Share this article:

Email Newsletters

More in News

Five things for pharma marketers to know: Friday, August 22

Five things for pharma marketers to know: Friday, ...

Two new indications give Eliquis more juice, a new rule is making hydrocodone harder to get and the ALS Ice Bucket Challenge highlights a controversial aspects of drug discovery and ...

Lilly takes on Amgen's Enbrel

Lilly takes on Amgen's Enbrel

Phase-III tests indicate Lilly's experimental treatment bests Amgen's for moderate-to-severe plaque psoriasis.

GSK Ellipta franchise expands

GSK Ellipta franchise expands

The FDA has approved Arnuity Ellipta for asthma.