Novartis AG (NVS) has announced results from a new analysis of its key heart failure drug Entresto (sacubitril/valsartan) which showed better performance compared to the old established drug Enalapril that was approved in 2013.
Entresto Improves Glycemic Control
New post hoc analysis of data on 3,778 diabetic patients confirmed that patients in the Entresto arm demonstrated reduced levels of HbA1c (a measure of blood sugar control level) by 0.26% against 0.16% observed in the group of patients taking enalapril. While Entresto isn’t a drug for treating diabetes, 29% fewer patients in the Entresto arm were required to start new insulin therapy, as compared to those in the enalapril arm. It opens up the prospects for the heart failure medicine to be potentially considered for expanded use for blood sugar management. With 40% of heart failure patients prone to have diabetes, the Novartis medicine can offer better therapy.
“These results show that in addition to its compelling cardiovascular efficacy, Entresto may have important metabolic benefits for HFrEF patients with diabetes,” said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis.
Based on a 2014 study, Novartis managed to secure the approval for Entresto in July 2015 for the treatment of heart failure. The drug was launched in the U.S. market in 2015 following a priority review approval by the U.S. Food And Drug Administration (FDA), but it missed to hit the sales projections due to its high price and slower reimbursements. Entresto sales clocked only $170 million last year, despite the company introducing a pay-for-performance deal with the payers. (For more, see Novartis Unveils Flexi-Pricing for Kisqali.)
Novartis has been looking to present additional data and reports to back the claims of drug’s superior efficacy, and the recently announced positive outcome has the potential to bolster its sales.
The drug, which is currently approved for heart failure patients with reduced ejection fraction, is being additionally evaluated in patients with preserved ejection fraction. Ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. The trial results are expected by 2019.
Another trial is assessing Entresto for cardiovascular problems and heart failure in patients who’ve had a heart attack, and the trial outcome is expected by 2020. (See also, Novartis Unveils Heart Failure Social Network.)