After scoring its first FDA nod as a treatment for heart failure patients three short months ago, AstraZeneca's Farxiga had its sights set on a game-changing approval in patients with or without diabetes. Monday, the FDA gave the SGLT2 med another push toward that goal.
The FDA granted Farxiga a priority review for reducing the risk of cardiovascular events in certain heart failure patients with or without Type 2 diabetes, a potential first in the SGLT2 class, AstraZeneca said.
Farxiga is currently approved to reduce the risk of hospitalizations in heart failure patients with a reduced ejection fraction (HFrEF) and Type 2 diabetes, as well as solo and combo approvals in diabetes proper.
The heart failure nod, granted in October, was based on outcomes trial data showing Farxiga cut the rate of hospitalizations by 36% among heart failure patients with a reduced ejection fraction and by 24% among those without one.
Farxiga already sports those benefits on its label in Europe, where it's known as Forxiga.
Farxiga previously trailed SGLT2 rivals like Johnson & Johnson's Invokana and Eli Lilly and Boehringer Ingelheim's Jardiance in marketing cardiovascular benefits but will take a major step ahead of both if it nabs this newest FDA green light.
The priority review comes on top of a fast-track designation Farxiga scored in September on the heels of trial data showing it cut CV risks by 26% when added to standard-of-care therapy for heart failure patients with or without Type 2 diabetes as part of its Dapa-HF outcomes trial.
In that study, Farxiga cut the combined risk of cardiovascular death or hospitalization in HFrEF. The FDA’s expedited review covered Farxiga’s pursuit of indications in both HFrEF and heart failure patients with a preserved ejection fraction, AstraZeneca said at the time.
On the same day Farxiga earned its priority review status, another AstraZeneca drug, Lokelma, scored a nod from Chinese regulators to treat hyperkalemia, or high concentrations of potassium in the blood.
Regulators based their decision on three clinical trials and one open-label trial in which hyperkalemia patients treated with Lokelma posted normal potassium levels in the blood at a median 2.2 hours after treatment. Lokelma also showed a rapid reduction in potassium an hour after treatment with a sustained effect up to a year later, AstraZeneca said.