Japan has approved AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D), the company notified in a statement.
The approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) is based on positive results from the DAPA-CKD phase-III trial. The decision follows the Priority Review designation granted by the MHLW earlier this year, the statement added.
Forxiga is the first-ever approved medicine for the treatment of the disease in Japan, informed the statement.
Speaking in this regard, the national coordinator of the DAPA-CKD phase-III trial in Japan, Naoki Kashihara, President, Japanese Society of Nephrology, said, “DAPA-CKD is the landmark trial that demonstrated unprecedented risk reduction for chronic kidney disease patients with and without type-II diabetes. This transformational milestone will bring great hope to many patients with chronic kidney disease in Japan.”
Adding to it, Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said, “This approval is an important step towards realising our ambition of improving outcomes for patients with chronic kidney disease. While new medicines like Forxiga advance the standard of care, we are also committed to the prevention and early detection of this often debilitating and life-threatening disease.”
According to the statement, the DAPA-CKD phase-III trial demonstrated that Forxiga, on top of standard-of-care (SoC) treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the relative risk of worsening of renal function, onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or renal death by 39 per cent, the primary composite endpoint, compared to placebo (absolute risk reduction [ARR]=5.3 per cent, p<0.0001) in patients with CKD stages two-to-four and elevated urinary albumin excretion. Forxiga also significantly reduced the relative risk of death from any cause by 31 per cent (ARR=2.1 per cent, p=0.0035) compared to placebo. The safety and tolerability of Forxiga were consistent with the well-established safety profile of the medicine.