AstraZeneca PLC (LSE:AZN) (LSE:AZN) announced that Forxiga has been approved in the EU for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes.
CKD is a serious, progressive condition defined by decreased kidney function and is often associated with an increased risk of heart disease or stroke.
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It affects 840mln people worldwide and 47mln in the EU, although diagnosis rates remain low and up to 90% of patients don’t know they have the disease.
The decision by the European Commission is based on positive results from a phase III trial and follows a positive recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
The candidate cut the risk of worsening of kidney function by 39% compared to placebo and risk of death from any cause by 31%.
It has already been approved in the US under the name Farxiga and is currently under review in Japan and several other countries around the world.
"Today's approval is an important milestone for Forxiga and has the potential to transform treatment for the millions of people living with chronic kidney disease in the EU,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D.
“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 FTSE 100 firm also unveiled positive results from a phase III trial on the Enhertu candidate used to help breast cancer patients.
The drug, developed with Daiichi Sankyo, showed a better outcome compared to the standard of care, trastuzumab emtansine (T-DM1).