Following the FDA’s decision to approve the first Entresto generics in May, the agency has told Novartis that its latest effort to block the copycat pill won’t go forward.
The FDA said in its response that Novartis’ latest citizen petition was similar to its first from 2021, and again explained why the Swiss drugmaker’s call for the agency to refrain from approving generics isn’t valid.
Although it’s unclear when the generics may launch, Entresto faces drug price negotiations with CMS as part of the first round of 10 drugs that are working their way through the process. CMS on Sept. 1 will unveil the new prices, which will take effect in 2026. Novartis sued in 2023 over its inclusion in the negotiations.
In its most recent petition, Novartis called on the FDA to not approve any Entresto generics due to potential label discrepancies with the brand-name version. But the FDA said in its new response that Entresto’s label was expanded in 2021 to include patients who could be categorized as having heart failure with preserved ejection fraction (HFpEF), and that indication can be carved out from generic labels.
“We conclude that ANDA applicants can omit this information to propose labeling for a generic sacubitril and valsartan product that does not seek approval for the purported use protected by the HFpEF Patents,” the FDA explained.
The FDA also said it has previously permitted the omission of an indication where the only way to omit the protected indication was to add words. The FDA offered the example of the cancer drug Velcade (bortezomib).
Entresto earned Novartis more than $6 billion in 2023 sales, and was first approved in 2015 for heart failure.