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Novartis Cites ‘Same Labelling’ Rule In FDA Entresto Petition

‘At Least Entresto 18 ANDAs Have Been Submitted To FDA,’ Novartis Reveals

 
• By Dean Rudge

Ahead of a proposed patent infringement trial set for September 2022, Novartis is urging the FDA not to approve any generic versions of its blockbuster heart failure therapy Entresto before February 2024 at the earliest, in part because of the agency’s own ‘same labelling’ regulations for ANDA products.

FDA building
The FDA approved the new indication in Feb. 2021 • Source: Shutterstock

With at least 18 ANDA sponsors submitting applications for a generic version of Novartis’ blockbuster heart failure therapy Entresto (sacubitril/valsartan), the Swiss originator has petitioned the US Food and Drug Administration to refrain from approving any generics before a key date in February 2024, in part because of a landmark new indication Novartis won for Entresto at the beginning of this year.

In a 29-page citizen petition submitted to the US regulator, Novartis points to its FDA approval in February 2021 of an expanded indication for heart failure for preserved ejection fraction (HFpEF) to add to Entresto’s initial approval for heart failure with reduced ejection fraction (HFrEF)

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