27th Aug 2019 08:50
(Alliance News) - AstraZeneca PLC on Tuesday said the US has granted fast track designation for the development of Farixga as a treatment for renal failure in chronic kidney disease.
The US Food & Drug Administration's fast track programme is intended to accelerate development and review of new medicines for serious conditions where there is a need for more treatments.
The Farixga fast track designation was given to chronic kidney disease patients with type-2 diabetes and without and is for Farixga development "to delay the progression of renal failure and prevent cardiovascular and renal death".
Mene Pangalos, executive vice president of biopharmaceuticals research & development at AstraZeneca, said: "Chronic kidney disease affects an estimated 37 million people in the US, and is often associated with an increased risk of heart disease and stroke. This fast track designation is an important step towards more quickly addressing unmet treatment needs in chronic kidney disease, and we will work closely with the FDA to explore the potential for Farxiga to improve outcomes for these patients."
A phase three clinical trial, Dapa-CKD, is ongoing with the goal of evaluating Farixga in chronic kidney disease in terms of renal outcomes and cardiovascular mortality.
Shares in AstraZeneca were down 1.3% at 7,220.00 pence in London on Tuesday morning.
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