FDA approves new treatment for HF

The FDA has approved a first-in-class angiotensin receptor-neprilysin inhibitor for the reduction of CV death and HF-related hospitalization among patients with HF and reduced ejection fraction, according to a press release.

Entresto (Novartis), formerly known as LCZ696, combines the angiotensin receptor blocker valsartan bonded to the neprilysin inhibitor sacubitril. The drug is administered in tablet form twice a day, in place of an ACE inhibitor or angiotensin receptor blocker.

The approval follows results of the PARADIGM-HF trial, which included 8,442 adults with NYHA class II, III or IV HF and reduced ejection fraction. The trial was stopped early due to significant reductions in the risk for CV death and HF-related hospitalization among patients treated with the drug compared with enalapril.

The most frequently observed adverse effects among patients who received Entresto included hypotension, hyperkalemia and renal impairment, according to an FDA press release. Angioedema also occurred among some patients, and the FDA warned against administering this drug in combination with an ACE inhibitor due to increased angioedema risk.

The very meaningful survival advantage of Entresto seen in the PARADIGM-HF trial should persuade physicians to consider Entresto for all appropriate patients, in place of traditional ACE inhibitors or angiotensin receptor blockers,”Milton Packer, MD, professor and chair of the department of clinical sciences at University of Texas Southwestern Medical Center, said in the release. “Entresto is expected to change the management of patients with [HF with reduced ejection fraction] for years to come.”

Entresto was approved through the FDA’s priority review program and had received fast track designation in order to expedite the review process. The drug is also currently under review in Canada, Switzerland and the European Union, according to the release.

Source: www.healio.com