25 Jan 2021
Posted in Pharma
Forxiga’s priority review and breakthrough designation highlight potential to differentiate in CKD space, says GlobalData
Forxiga’s (dapagliflozin) latest priority review by the FDA for chronic kidney disease (CKD) further signifies the drug’s major advantages over existing treatments and will provide enhanced support for its development in targeting reduced glomerular filtration rate (GFR) and all-cause death. If approved, Forxiga will likely be used as a novel standard of care (SoC) option for CKD and help to enhance patient compliance.
Kajal Jaddoo, Associate Pharma Analyst at GlobalData, comments: “As the pathophysiology of CKD is most often tracked through an analysis of GFR, Forxiga’s approval is significant as it can potentially reduce pressure in the glomeruli of the kidney. Additionally, Forxiga is the first sodium glucose co-transporter 2 (SGLT2) inhibitor to prolong survival for CKD patients and provide organ protection, according to data from the DAPD-CKD trial. According to GlobalData’s Pharma Intelligence Center (PIC) drug database, there are two SGLT2 inhibitors in late-stage development and one SGLT2 inhibitor marketed for CKD: Boehringer Ingelheim’s Jardiance, AstraZeneca’s Forxiga and Janssen’s Invokana.”
Forxiga is an SGLT2 inhibitor in development for CKD. The DAPA-CKD trial demonstrated that Forxiga in combination with SoC, specifically consisting of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, lowered the composite risk of worsening renal function by 39% compared to placebo (risk lowered by 5.3%, p<0.0001). Additionally, there was a significant (31%) reduction in risk of death from any cause compared to placebo, and Forxiga’s safety and tolerability data were in line with its existing safety profile.
Jaddoo continues: “The DAPA-CKD trial was stopped early in March 2020 due to recommendations by an independent data monitoring committee that concluded the trial showed ‘overwhelming efficacy’. This positive trial data supported Forxiga’s priority review since it offers significant advances over available options and demonstrated better efficacy, thus preventing risk cardiovascular and renal death.”
People with early-stage kidney disease often do not have symptoms. As a result, CKD is systematically underdiagnosed.
Jaddoo concludes: “According to the Epidemiology Database within GlobalData’s PIC, the number of total prevalent cases of stage I–IV chronic kidney disease in the US, France, Germany, Italy, Spain, UK, and Japan is estimated to grow from approximately 106 million cases in 2020 to approximately 115 million cases by 2026. The Prescription Drug User Fee Act date for Forxiga in CKD is expected in Q2 2021.”