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Biotech Stocks Facing FDA Decision In April 2021

AstraZeneca
AstraZeneca

AstraZeneca PLC’s (AZN) Farxiga, proposed for the expanded use in the treatment of new or worsening chronic kidney disease in adults with and without type-2 diabetes, awaits the FDA decision, which can be expected during the second quarter.

Chronic kidney disease (CKD), a condition defined by decreased kidney function, is often associated with a heightened risk of heart disease or stroke, or the need for dialysis or kidney transplant. CKD is expected to become the world’s fifth leading cause of mortality by 2040. Currently, about 37 million people are estimated to have CKD in the U.S.

Farxiga, a first-in-class, oral, once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor, has been an effective monotherapy and part of combination therapy as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes for nearly a decade.

The drug raked in total annual sales of $1.93 billion in 2020, up 27% over the prior year.

Farxiga is estimated to achieve peak sales of $9 billion by 2028, according to GlobalData, a market research company.

AZN closed Friday’s (Mar.26, 2021) trading at $50.64, up 1.89%.