Degludec Advisory Committee Is Another De Facto Delay For Novo
This article was originally published in The Pink Sheet Daily
FDA’s advisory committee meeting on Nov. 8 falls just after the already-extended user fee date for Novo Nordisk’s long-acting insulin degludec and degludec/insulin aspart.
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In briefing documents for the Nov. 8 panel review, FDA suggests the clinical trial data do not support Novo Nordisk’s assertion of a hypoglycemia advantage with its new long-acting insulin. Agency also raises concerns about a meta-analysis suggesting an increased cardiovascular risk.
Investors appear upbeat about a Nov. 8 FDA advisory committee on Novo Nordisk’s next-generation insulin degludec (Tresiba), despite some concerns on the cardiovascular safety front.
Novartis and Novo Nordisk receive first global approvals for compounds in Japan in recent slate of approvals, along with a wave of government-subsidized orphan drugs.