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Xultophy Expands Label In Europe As First US Approval Decision Looms

 
• By Lucie Ellis-Taitt

Novo Nordisk has secured a European label extension for its dual type 2 diabetes therapy Xultophy for use in patients with moderate renal impairment – the EU nod is a another boost of confidence the Danish firm needs as it awaits a US regulatory decision.

The European Commission has approved the use of Novo Nordisk AS' Xultophy, a first-to-market once-daily combination of long-acting basal insulin Tresiba and glucagon-like peptide-1 receptor agonist Victoza in one pen, for use in type 2 diabetes patients with moderate renal impairment.

Xultophy's new drug application for use in type 2 diabetes patients is still pending at the US FDA, with a...

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