9th Aug 2021 08:46
(Alliance News) - AstraZeneca PLC's Forxiga drug has been approved in the European Union for the treatment of chronic kidney disease, the drugmaker announced on Monday.
The approval by the European Commission 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.
"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," 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."
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.
In a separate announcement, AstraZeneca said the use of its Enhertu drug had been proven to lead to a "strong trend toward improved overall survival" in results from its head-to-head Destiny-Breast03 Phase III.
The trial's results showed that Enhertu demonstrated superiority over trastuzumab emtansine, another possible treatment, in patients with HER2-positive metastatic breast cancer.
Enhertu was developed by AstraZeneca in partnership with Daiichi Sankyo Company Ltd, and targets patients with HER2-positive breast cancer.
"These transformative progression-free survival results demonstrate the superiority of Enhertu compared to trastuzumab, and the encouraging safety data may open future opportunities to bring this benefit to patients in earlier treatment settings," said Executive Vice President of Oncology Research & Development Susan Galbraith.
AstraZeneca's plans for global regulatory submissions for Enhertu are now underway, it noted.
Shares were trading up 0.6% at 8,202.24 pence each early on Monday morning in London.
By Will Paige; [email protected]
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