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(Alliance News) - AstraZeneca PLC on Monday said it received two treatment approvals in the US and in China respectively.
The Cambridge-based pharmaceutical firm said the US Food & Drug Administration approved Imfinzi to treat adults with locally advanced or metastatic biliary tract cancer.
BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder.
It said the approval was based on Topaz-1 Phase III trial, which showed Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone.
AstraZeneca Executive Vice President Dave Fredrickson said: "For the first time, patients in the US with advanced biliary tract cancer have an immunotherapy-based treatment option that meaningfully extends survival and is well-tolerated. This approval for Imfinzi and chemotherapy advances our ambition to challenge treatment expectations and transform care for patients with gastrointestinal cancers with high unmet need."
Astra also said it received approval from China's National Medical Products Administration for Forxiga to treat chronic kidney disease in patients at risk of progression with and without type-2 diabetes.
The firm noted the approval was based on positive results from the DAPA-CKD Phase III trial.
CKD is a progressive condition defined by decreased kidney function and is often associated with an increased risk of heart disease or stroke. It affects about 850 million people worldwide.
Fan Fan Hou of Southern Medical University in Guangzhou said: "With unprecedented results of DAPA-CKD, dapagliflozin becomes the first SGLT2 inhibitor approved in China for the treatment of chronic kidney disease. This transformational milestone brings great hope to the 120 million subjects suffering from chronic kidney disease in China."
Astra shares were down 1.8% at 10,430.00 pence each on Monday morning in London.
By Xindi Wei; xindiwei@alliancenews.com
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