FDA Accepts Supplemental NDA for AstraZeneca’s Heart Failure Drug

The sNDA was accepted after positive results from a Phase III trial were published in September 2019 that concluded the drug reduced the incidence of cardiovascular death or the worsening of heart failure versus placebo.

AstraZeneca announced on Jan. 6, 2020 that FDA has accepted a supplemental new drug application (sNDA) for Farxiga (dapagliflozin), an oral once-daily sodium-glucose co-transporter 2 inhibitor, in which the company is seeking approval for use of the drug to reduce the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction with and without type-2 diabetes. FDA has also granted the sNDA priority review.

The sNDA was accepted after positive results from a Phase III trial were published in September 2019 that concluded the drug reduced the incidence of cardiovascular death or the worsening of heart failure versus placebo, according to a company press release. That same month, FDA granted fast track designation to Farxiga for heart failure.

The FDA action date for the drug will occur in the second quarter of 2020.

“Farxiga is well established in the treatment of type-2 diabetes and this priority review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, in the press release.

Source: AstraZeneca