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AstraZeneca gets new Imfinzi approval, posts positive Farxiga results
1st Sep 2020 07:28
(Sharecast News) - AstraZeneca announced on Tuesday that 'Imfinzi', or durvalumab, has been approved in the European Union for the first-line treatment of adults with extensive-stage small cell lung cancer, in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.
The FTSE 100 drugmaker also said that detailed results from the phase 3 'DAPA-CKD' trial showed that 'Farxiga', or dapagliflozin, on top of standard of care reduced the worsening of renal function or risk of cardiovascular or renal death by 39% compared to placebo in patients with chronic kidney disease stages two to four and elevated urinary albumin excretion.
It said the approval of Imfinzi by the European Commission was based on positive results from the phase 3 'CASPIAN' trial, showing Imfinzi plus chemotherapy demonstrated a "statistically significant and clinically meaningful" overall survival benefit for the first-line treatment of patients with extensive-stage small cell lung cancer.
The approval followed the recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency in July.
"Imfinzi plus chemotherapy is becoming a new global standard of care for patients with extensive-stage small cell lung cancer, and we are pleased to bring this option to patients in Europe who urgently need it," said executive vice-president of the oncology business unit, Dave Fredrickson.
"This is the first immunotherapy regimen to offer both a sustained survival benefit and an improved response rate, as well as a choice of chemotherapies and convenient dosing every four weeks during maintenance."
For the Farxiga results, AstraZeneca said they were consistent in patients both with and without type-2 diabetes.
It described chronic kidney disease as a "serious, progressive condition" defined by decreased kidney function, which affects almost 700 million people worldwide - many of them still undiagnosed - with the most common causes being diabetes, hypertension and glomerulonephritis.
The primary composite endpoint was more than a 50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end-stage kidney disease and cardiovascular or renal death.
It said the absolute risk reduction was 5.3% over the median time in study of 2.4 years.
The trial also met all secondary endpoints, including significantly reducing death from any cause by 31% compared to placebo.
"With today's results, Farxiga becomes the first SGLT2 inhibitor proven to significantly prolong the survival of patients with chronic kidney disease with and without type-2 diabetes and we look forward to sharing these data with regulatory authorities around the world," said Mene Pangalos, executive vice-president of biopharmaceuticals research and development.
"Farxiga is also the first medicine in its class to demonstrate benefit in treating both heart failure and chronic kidney disease in patients with and without type-2 diabetes, and reduce the risk of hospitalisation for heart failure and nephropathy in type-2 diabetes."
At 0826 BST, shares in AstraZeneca were up 1.13% at 8,434p.
The FTSE 100 drugmaker also said that detailed results from the phase 3 'DAPA-CKD' trial showed that 'Farxiga', or dapagliflozin, on top of standard of care reduced the worsening of renal function or risk of cardiovascular or renal death by 39% compared to placebo in patients with chronic kidney disease stages two to four and elevated urinary albumin excretion.
It said the approval of Imfinzi by the European Commission was based on positive results from the phase 3 'CASPIAN' trial, showing Imfinzi plus chemotherapy demonstrated a "statistically significant and clinically meaningful" overall survival benefit for the first-line treatment of patients with extensive-stage small cell lung cancer.
The approval followed the recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency in July.
"Imfinzi plus chemotherapy is becoming a new global standard of care for patients with extensive-stage small cell lung cancer, and we are pleased to bring this option to patients in Europe who urgently need it," said executive vice-president of the oncology business unit, Dave Fredrickson.
"This is the first immunotherapy regimen to offer both a sustained survival benefit and an improved response rate, as well as a choice of chemotherapies and convenient dosing every four weeks during maintenance."
For the Farxiga results, AstraZeneca said they were consistent in patients both with and without type-2 diabetes.
It described chronic kidney disease as a "serious, progressive condition" defined by decreased kidney function, which affects almost 700 million people worldwide - many of them still undiagnosed - with the most common causes being diabetes, hypertension and glomerulonephritis.
The primary composite endpoint was more than a 50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end-stage kidney disease and cardiovascular or renal death.
It said the absolute risk reduction was 5.3% over the median time in study of 2.4 years.
The trial also met all secondary endpoints, including significantly reducing death from any cause by 31% compared to placebo.
"With today's results, Farxiga becomes the first SGLT2 inhibitor proven to significantly prolong the survival of patients with chronic kidney disease with and without type-2 diabetes and we look forward to sharing these data with regulatory authorities around the world," said Mene Pangalos, executive vice-president of biopharmaceuticals research and development.
"Farxiga is also the first medicine in its class to demonstrate benefit in treating both heart failure and chronic kidney disease in patients with and without type-2 diabetes, and reduce the risk of hospitalisation for heart failure and nephropathy in type-2 diabetes."
At 0826 BST, shares in AstraZeneca were up 1.13% at 8,434p.