In a new chapter for the ongoing story of sodium glucose transporter-2 inhibitor (SGLT2) inhibitors, Boehringer Ingelheim International GmbH and Eli Lilly and Co.'s Jardiance (empagliflozin) has become the first therapy of the class to significantly reduce the risk of cardiovascular death or hospitalization vs. placebo for heart failure patients with preserved ejection fraction (HFpEF). The finding comes from the phase III Emperor-Preserved study, which tested once-daily Jardiance 10 mg vs. placebo in nearly 6,000 adults living with HFpEF, with and without diabetes.
Vericiguat became the first oral soluble guanylate cyclase stimulator to win FDA approval for use in heart failure patients. The drug, branded Verquvo, was developed by Merck & Co. Inc. as part of a $1 billion deal with Bayer AG. But its commercial potential could be hampered by its modest clinical efficacy and increasing competition in the space, as well as difficulties launching a new drug during a pandemic.
With so much ire in Congress directed toward U.S. prescription drug prices in 2019, it’s not surprising that prices remained relatively stable that year. That’s not to say there weren’t price hikes. In its second report on unsupported price increases, the Institute for Clinical and Economic Review (ICER) identified nine of the 100 top-selling drugs that had list price increases more than double the rate of medical inflation in 2019 and that accounted for the largest increases in U.S. spending on drugs.
Bayer AG and Merck & Co. Inc. took Wall Street by surprise in November with their phase III success testing vericiguat in heart failure (HF), such that the guanylate cyclase stimulator’s odds not only have improved significantly but also in a different way than imagined before.
The failure of Novartis AG's Entresto in a phase III clinical trial staggered the stock (NASDAQ:NVS) somewhat Monday, down just 1.14%, but the real trauma may well be the loss of roughly $2.5 billion in anticipated sales.