FDA Denies Novartis’ Petition to Block Entresto Generics

 

In addition to facing generic competition, Entresto is among the initial 10 drugs selected for the Inflation Reduction Act’s Medicare Drug Price Negotiation Program, with the maximum fair prices to be published by Sept. 1.

The FDA last week denied the citizen petition submitted by Novartis, seeking to block the approval and entry of generic versions of its oral heart failure drug Entresto (sacubitril and valsartan).

Novartis filed its petition in September 2022, outlining three main requests, according to the FDA’s letter. First, the pharma asked FDA to deny approving any application referencing Entresto until after Feb. 16, 2024, which is when the drug’s three-year exclusivity period under the Orange Book expires.

Novartis’ two other main requests related to specific Entresto patents—which are expected to expire August 22, 2033 and May 9, 2036, respectively. The pharma petitioned the FDA to refrain from approving drug applications that would otherwise breach these protections.

In its response, the regulator dismissed Novartis’ first request as moot, while simultaneously denying the second and third requests.

Of the three-year exclusivity period that the pharma was seeking, the FDA contends that “regardless of the scope of exclusivity” covering Entresto, these have all already expired. Meanwhile, the regulator rebuffed Novartis’ patent-specific appeals, noting that applicants seeking to develop generic versions of Entresto can tweak their labelling to avoid violating the drug’s existing protections.

“In accordance with our statutory and regulatory authority, we have determined that in this instance, an [abbreviated New Drug Application] may propose labeling for a generic sacubitril and valsartan product that does not seek approval for the purported use protected” by the patents in question, the FDA wrote in its letter.

Entresto is a combination of sacubitril, a neprilysin inhibitor, and valsartan, and angiotensin receptor blocker. This specific mix of drugs allows Entresto to lower vascular resistance and blood pressure, while also eliciting various renal benefits. The drug was first approved in 2015 for heart failure in adults and its scope has since been expanded to also cover pediatric patients as well as chronic heart failure.

The heart failure drug has consistently been a cornerstone of Novartis’ business. In 2023, the drug brought in more than $6 billion in net sales and was the pharma’s top-selling asset. In its most recent business report, Novartis posted net sales of $3.77 billion for Entresto in the first six months of 2024.

The Centers for Medicare and Medicaid Services has named Entresto as one of the first 10 drugs that would be affected by the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. Negotiations conclude this week with the final maximum fair prices scheduled to be revealed by Sept. 1. So far, Novartis has said that the impacts of this “price-setting program” are likely to be “manageable.”

https://www.biospace.com/fda/fda-denies-novartis-petition-to-block-entresto-generics