Sacubitril/Valsartan

The Inflation Reduction Act allows CMS to negotiate Medicare drug prices, exposing patent abuses like evergreening. Four of 10 drugs would have faced competition, saving Medicare $4.9-$5.4B. Nine drugs show evidence of anticompetitive patent practices, delaying affordable alternatives. CMS must consider these practices to ensure fair prices for Medicare beneficiaries.

SUMMIT trial shows tirzepatide reduces cardiovascular death or worsening heart failure events in obese HFpEF patients, with significant improvements in quality of life, functional capacity, weight, and systemic inflammation. Tirzepatide's benefits are consistent across subgroups, though the mechanism of its HF benefit remains unclear.

Novartis v. MSN Pharms., Civ. No. 20-MD-2930-RGA, 2024 WL 3756787 (D. Del. Aug. 12, 2024): Novartis sued MSN for infringing the ’918 patent on Entresto®. After FDA approval, Novartis sought a preliminary injunction. The court denied it, finding no likelihood of success on merits or irreparable harm. Novartis plans to appeal.

Novartis v. Hetero USA Inc. (2024 WL 3757086) involves a Hatch-Waxman patent infringement action over Entresto®. The court found the ’659 patent invalid for lack of written description, denying Novartis’s injunction request pending appeal. Judge Andrews was skeptical of Novartis’s claims of irreparable harm, noting that MSN’s launch should not be blamed for other generic drug makers’ actions or Novartis’s business decisions. The court granted a temporary stay for Novartis to seek relief from the Federal Circuit.

Eligible healthy African American men and women without diabetes, heart disease, or kidney problems can participate in a study on sacubitril/valsartan's effects on sugar handling. The study involves exercise, medication, and blood samples, with $675 compensation for completion. Contact Tiffany at 205-934-0534 or nauticalstudy@uabmc.edu.

Finerenone reduced CV death and worsening HF risk by 16% in HF patients with mildly reduced or preserved ejection fraction, per FINEARTS-HF trial. Pooled analyses showed benefits of finerenone and MRAs in high-risk patients.

Dr. Atsushi Tanaka presented the Premier study findings at ESC, showing sacubitril/valsartan (Sac/Val) prompts greater N-terminal pro-brain natriuretic peptide reduction in Japanese acute HF patients without increased adverse events. Key opinion leaders emphasize Sac/Val's use in hospitalized HF patients, considering its revolutionary impact in reducing cardiovascular deaths and hospitalizations. Launched as Entresto in 2015, Sac/Val's efficacy in acute HF management represents a significant opportunity.