(Reuters) – AstraZeneca’s diabetes drug, Farxiga, has been granted fast track designation by U.S. regulators for the treatment of heart failure, boosting prospects of wider use of the drug and putting it ahead of rivals.
The U.S. Food and Drug Administration (FDA) granted the status for development of the drug to reduce the risk of deadly heart attacks and disease progression in adults with the HFrEF and HFpEF subtypes of heart failure, the British drugmaker said on Monday.
Farxiga, already approved as a treatment for type-2 diabetes, is part of the SGLT2-inhibitor class of antidiabetics that cause the kidneys to expel blood sugar from the body through urine. Diabetes is often associated with a high risk of heart failure.
AstraZeneca made strides last month towards its goal of adding heart failure to the conditions that can be treated by Farxiga, putting it ahead of a rival medicine from Eli Lilly, following positive results in a late-stage trial seen as a ‘wild-card’ by the market.
Farxiga is one of AstraZeneca’s top 10 drugs by sales. It generated $1.39 billion in 2018, and is key to its future as it turns itself around.
Farxiga’s fast track designation in heart failure was based on two late-stage clinical trials. In one study, around 40% of participants suffered from type-2 diabetes, as is common among heart failure patients, while the rest did not.
The FDA’s fast track programme https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track is designed to speed up the development and review of new medicines for the treatment of serious conditions where there is an unmet need.
Heart failure affects about 64 million people worldwide and half of the patients die within five years of diagnosis, AstraZeneca said.
(Reporting by Pushkala Aripaka and Noor Zainab Hussain in Bengaluru; Editing by Saumyadeb Chakrabarty)