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- by Jan 28, 2021 05:59am
AstraZeneca¡¯s Forxiga has been approved in South Korea to treat diabetes and heart failure. The indication is obtained for the first time for a sodium-glucose co-transporter-2 (SGLT2) inhibitor.
The industry experts noted, ¡°Forxiga demonstrated reduction of cardiovascular death risk and hospitalization for heart failure in patients with or without diabetes.¡±
In 2014, Forxiga was the first SGLT-2 inhibitor to be released in the South Korean market. Although initially developed as a type-2 diabetes treatment, a series of clinical studies showed a potential in reducing risk of cardiovascular and renal diseases. And in last December, the drug won the indication to lower the risk of heart failure based on additional study results.
During a virtual online media conference convened on Jan. 25 by AstraZeneca Korea, experts projected the SGLT-2 inhibitor would bring a new change in the heart failure treatment scene.
Mediating the conference, President Choi Dong-ju (Seoul National University Bundang Hospital Department of Internal Medicine) of the Korean Society of Heart Failure (KHFS) evaluated, ¡°A SGLT-2 inhibitor acquiring an indication to treat heart failure holds a great significance. Along with the changes in drug use, the global cardiology association¡¯s guidelines are changing accordingly as well.¡±
In fact, the American College of Cardiology (ACC) has released the 2020 Expert Consensus Decision Pathway recommending cardiologists to choose SGLT-2 inhibitor of glucagon-like peptide 1 receptor agonists (GLP-1RA) over the previously recommended metformin, to treat patients who have been diagnosed with or have a high risk of cardiovascular disease.
Also the practical guidance for cardiologist updated after four years recommends administering SGLT-2 inhibitor combination as a standard of care (SOC) for NYHA class II-IV patients who meet the estimated glomerular filtration rate (eGFR) standard and have heart failure with reduced ejection fraction.
Professor Choi Seonghoon (Hallym University Medical Center Department of Cardiology) stated, ¡°Particularly, the revised ACC guideline positioned SGLT-2 inhibitor as a second-line therapy for heart failure. Considering various efficacies Forxiga has confirmed, it would be helpful to use the drug as soon as possible for better treatment result.¡±
The Phase III DECLARE-TIMI 58 study, evaluating Forxiga¡¯s cardiovascular safety in type-2 diabetic patients, confirmed the drug reduced the risk of hospitalization for heart failure or cardiovascular death. And DAPA-HF study proved the drug¡¯s effect to treat chronic heart failure patients regardless of type-2 diabetes.
Professor Choi Seonghoon elaborated, ¡°The DAPA-HF study presented highly significant data showing Forxiga lowering the risk of worsening heart failure by 30 percent, and the risk of cardiovascular death by 18 percent, especially because the clinical data proved the simple but integral benefit of combining Forxiga on the standard of care.¡±
Another participant at the conference, Professor Kim Eung-ju (Korea University Guro Hospital Cardiovascular Center) positively highlighted Forxiga can provide double benefit as it was effective in renal disease, most frequently expressed in patients with heart failure.
Professor Kim said, ¡°In the DECLARE-TIMI 58 study, Forxiga lowered the eGFR by minimum 40 percent, compared to placebo, and the risk of renal disease death by 59 percent. Considering cardiovascular and renal diseases are closely related, SGLT-2 inhibitor could deliver a dual effect in heart and kidney.¡±
Led by Forxiga, the SGLT-2 inhibitor prescription volume is expected to surge even higher as it expands indication.
According to UBIST, the SGLT-2 inhibitor market generated 121.4 billion won last year. Compared to 12.2 billion won made in 2015, the prescription volume skyrocketed by 895 percent in just five years. Out of the total prescription volume, AstraZeneca¡¯s Forxiga combination drug with metformin Xigduo takes up the biggest pie with 64.8 billion won.