The Food and Drug Administration (FDA) has approved the first generics of Entresto® (sacubitril and valsartan; Novartis) tablets.
The combination of sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin II receptor blocker, is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure, and for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged 1 year and older.
Sacubitril/valsartan tablets will be supplied in 24mg/26mg, 49mg/51mg, 97mg/103mg dosage strengths. The availability of these generics is still unclear as the patent for Entresto does not expire until July 15, 2025.
According to the FDA, Entresto tablets were identified by the Centers for Medicare & Medicaid Services as one of the costliest drugs under Medicare Part D. In October 2023, it was announced that Novartis would participate in direct negotiations with Medicare in an effort to lower drug costs for beneficiaries.
This article originally appeared on MPR
References:
- US Food and Drug Administration. FDA Roundup: May 31, 2024. Accessed June 3, 2024. https://www.fda.gov/news-events/press-announcements/fda-roundup-may-31-2024.
- Biden-Harris Administration moves forward with Medicare drug price negotiations to lower prescription drug costs for people with Medicare, News release. October 3, 2023. Accessed June 3, 2024. https://www.hhs.gov/about/news/2023/10/03/biden-harris-administration-moves-medicare-drug-price-negotiations-lower-prescription-drug-costs-people-medicare.html.
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- Source: https://www.renalandurologynews.com/general-medicine/fda-approves-first-generics-of-heart-failure-combo-drug-entresto/