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Summary
- AstraZeneca announced that it has been granted the Priority Review in the US foe Farxiga
- If approved, Farxiga (dapagliflozin) could be used in treating the patients of chronic kidney disease
AstraZeneca PLC (LON: AZN) announced on Wednesday that it has received Priority Review of Farxiga (dapagliflozin) in the US for the treatment of the new chronic kidney disease that is found in adults with and without type-2 diabetes. The Prescription Drug User Fee Action date will be somewhere in Q2 2021.
The priority review are granted by the FDA (Food and Drug Administration), the US regulator to monitoring submissions for those medicines that offer noteworthy advances over the existing medicine.
The clinical evidence from the DAPA-CKD Phase III trial was the basis on which the regulatory submission was accepted by the FDA and the Priority Review was granted.
Clinical trials
The trial showed that Farxiga, that consisted of an ACEi (angiotensin-converting enzyme inhibitor) or an ARB (angiotensin receptor blocker), minimised the danger of the composite of failing of renal function or danger of cardiovascular or renal bereavement by 39 per cent in contrast to placebo and raised the urinary albumin excretion. The risk of death was also substantially reduced from any cause by 31 per cent in contrast to placebo.
The clinical trials demonstrated that the safety and tolerability of Farxiga was steady and in line with well-established safety profile of the medicine.
An independent Data Monitoring Committee had recommended the trial to be stopped by March 2020, when the overall efficacy of the medicine was vast.
Farxiga was ratified in May 2020 in the United States, as it was able to minimise the risk of deaths occurring from CV and hospitalisation for heart failure in grownups.
Farxiga received Revolutionary Therapy Designation in the US in October 2020, for patients with CKD as well as those not including T2D.
Chronic Kidney Disease
Chronic Kidney Disease, also known as CKD, is a condition defined by reduced kidney performance, which usually leads to heart disease or cerebrovascular accident, and can also require dialysis or even kidney transplant. Diabetes, glomerulonephritis and high blood pressure are the commonly known reasons which result into CKD. This serious, progressive condition that has been affecting approximately 850 million people all over the world.
The Executive Vice President of BioPharmaceuticals R&D, Mene Pangalos said the approval of Priority Review had brought the company very close to producing the new therapy choice for the millions of patients that have been suffering from the prolonged kidney ailment in the US.
He added that Farxiga had the ability to be a real revolutionary medicine across a range of ailments such as type-2 diabetes, heart malfunction, etc.
