UK-based pharmaceutical major AstraZeneca plc (AZ, NASDAQ: AZN) has announced that China’s National Medical Products Administration (NMPA) has granted a new indication approval for its SGLT-2 inhibitor, Forxiga (dapagliflozin). The drug is now approved to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), or urgent HF visits in adults with symptomatic chronic HF.
Expansion of Forxiga’s Indications in China
Previously, Forxiga was approved in China to treat heart failure patients with reduced ejection fraction (HFrEF). This new approval expands its use to include all HF patients, regardless of ejection fraction status. Forxiga, an SGLT2 inhibitor, was the first of its class to be approved in China for controlling type 2 diabetes in March 2017. The HFrEF indication was added in February 2021, and the drug has been nationally reimbursed since 2019.
Clinical Trial Success and Patient Impact
The DELIVER and DAPA-HF Phase III trials have demonstrated that Forxiga is the first HF medication to show a mortality benefit across the full ejection fraction range. Heart failure, a condition where the heart is unable to pump sufficient blood around the body, affects approximately 4.5 million patients in China each year, with about half of these patients dying within five years of diagnosis.
Market Implications and Competitive Moat
This new approval may provide AstraZeneca with a competitive advantage against generic competitors in China. The UK pharmaceutical giant recently faced a setback in a patent linkage challenge, resulting in four generic versions of the drug now being available in the Chinese market. Despite this, Forxiga remained AZ’s top-selling drug in 2022, with sales reaching USD 4.386 billion, marking a 56% year-on-year growth.-Fineline Info & Tech
