(Alliance News) - AstraZeneca PLC has been granted approval in Japan for the use of its Forxiga drug to treat chronic kidney disease, the drugmaker said on Thursday.
The approval by Japan's Ministry of Health, Labour & Welfare is based on positive results from the DAPA-CKD Phase III trial and will see adults with and without type-2 diabetes being eligible for treatment.
"This approval is an important step towards realising our ambition of improving outcomes for patients with chronic kidney disease," commented Mene Pangalos, executive vice president at Astra's BioPharmaceuticals Research & Development unit.
"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."
The regulator's decision follows the announcement earlier this month of the European Commission granting approval for Forxiga's use in the EU.
Chronic kidney disease affects around 840 million globally and is a progressive condition defined by decreased kidney function, often associated with an increased risk of heart disease or stroke.
Forxiga has been proven to help reduce the relative risk of worsening renal function, onset of end-stage kidney disease, or risk of cardiovascular or renal death.
Separately, the Anglo-Swedish durugmaker said its ALXN1840 FoCus Phase III trial into Wilson disease demonstrated improvement in copper mobilisation from tissues and met its primary endpoint.
The positive results showed around three times greater copper mobilisation from tissues than standard-of-care treatments.
Wilson disease is a rare and progressive genetic condition in which the body's pathway for removing excess copper is compromised, causing damage from toxic copper build-up and potentially leading to liver disease.
ALXN1840, a potential new oral medicine, demonstrated approximately three times greater copper mobilisation than traditional treatments, Astra noted.
Shares were trading up 0.4% at 8,583.00 pence each early on Thursday morning in London.
By Will Paige; willpaige@alliancenews.com
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