Investigational Heart Failure Drug Granted Priority Review

Article

The FDA recently granted priority review to Novarits' investigational drug LCZ696, a potential treatment for heart failure with ejection fraction.

The FDA recently granted priority review to Novarits’ investigational drug LCZ696, a potential treatment for heart failure with ejection fraction (HFrEF).

LCZ was designed with a unique mechanism of action that boosts the heart’s protective neurohormonal systems while suppressing its more harmful systems, alleviating the strain on the heart.

Novartis submitted a New Drug Application for LCZ696 under the FDA’s Fast Track program, supporting the submission with data from a study comparing the drug with the common angiotensin-converting enzyme inhibitor, enalapril. The research team deemed twice-daily LCZ696 superior to enalapril in reducing the risk of cardiovascular death or heart failure-related hospitalization, as patients treated with LCZ696 reported better progress than those treated with enalapril.

LCZ696 maintained an acceptable safety profile throughout the trial.

“LCZ696 is a demonstration of our commitment to developing innovative medicines that improve important heart failure related outcomes such as cardiovascular mortality, hospitalization and quality of life,” said Novartis Pharmaceuticals Division Head David Epstein in a press release. “The FDA’s decision reflects the significant need to extend and improve life for HFrEF patients and Novartis is working to ensure LCZ696 can become available in the US as soon as possible.”

Given the reduced review time for drugs with priority review designation, the FDA could make a decision on LCZ696’s approval as early as August 2015.

Related Videos
Laboratory test tubes and solution with stethoscope background | Image Credit: Shutter2U - stock.adobe.com
Image credit: Andrea Izzotti
Inflation Reduction Act is shown using the text and the US flag - Image credit: Andrii | stock.adobe.com
Pharmacy Interior | Image Credit: Tyler Olson - stock.adobe.com
Patient with diabetes testing blood sugar levels
Male pharmacist selling medications at drugstore to a senior woman customer | Image Credit: Zamrznuti tonovi - stock.adobe.com
Pharmacist assists senior woman in buying medicine in pharmacy - Image credit: Drazen | stock.adobe.com
Pharmacy, medicine and senior woman consulting pharmacist on prescription. Healthcare, shopping and elderly female in consultation with medical worker for medication box, pills or product in store - Image credit: C Daniels/peopleimages.com | stock.adobe.com
Image credit: fidaolga - stock.adobe.com
Pharmacists checking inventory at hospital pharmacy- Image credit: Jacob Lund | stock.adobe.com
© 2023 MJH Life Sciences

All rights reserved.