AstraZeneca clears regulatory hurdles in US and China
AstraZeneca cleared two regulatory approvals on Monday - one for ‘Farxiga’ in the United States, and one for ‘Lokelma’ in China.
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The FTSE 100 pharmaceutical giant said that in the US, the Food and Drug Administration (FDA) accepted a supplemental new drug application (sNDA) and granted ‘priority review’ status for Farxiga, or dapagliflozin, to reduce the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF), with and without type-2 diabetes.
It described Farxiga as a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2.
The Prescription Drug User Fee Act date - the FDA action date for the supplemental application - was scheduled for the second quarter of 2020.
AstraZeneca said the sNDA was based on results from the landmark phase 3 DAPA-HF trial published in September in the New England Journal of Medicine, which showed Farxiga on top of standard of care reduced the incidence of the composite outcome of cardiovascular death or the worsening of heart failure, compared to placebo.
“Farxiga is well established in the treatment of type-2 diabetes and this priority review shows its potential to also impact millions of patients with heart failure,” said Mene Pangalos, executive vice-president of biopharmaceuticals research and development.
“If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure.”
In September, the FDA granted ‘fast track’ designation for the development of Farxiga in heart failure.
Earlier, in August, the FDA also granted fast track designation for the development of Farxiga to delay the progression of renal failure and prevent cardiovascular and renal death in patients with chronic kidney disease, with and without type-2 diabetes.
Farxiga is indicated as a monotherapy and as part of combination therapies to improve glycaemic control in adults with type-2 diabetes.
In October, the FDA also approved Farxiga to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes, and established cardiovascular disease or multiple cardiovascular risk factors.
In China, AstraZeneca said ‘Lokelma’, or sodium zirconium cyclosilicate, has been approved for the treatment of adult patients with hyperkalaemia, or elevated levels of potassium in the blood.
The company said the approval by the National Medical Products Administration (NMPA) was based on positive results from the “extensive” Lokelma clinical trial programme and a pharmacodynamic study in China, which showed that patients receiving Lokelma experienced a “significant, rapid and sustained reduction” of potassium in the blood.
In 2019, the NMPA included Lokelma on the ‘accelerated approval’ list of ‘Overseas New Drugs in Clinical Urgent Needs for China’, which AstraZeneca said recognised the “significant unmet need” for effective medicines treating hyperkalaemia.
“This approval marks an important milestone for more than two million patients in China who suffer from hyperkalaemia,” said Mene Pangalos.
“Lokelma will offer the opportunity for patients and physicians to achieve long-term disease control and potentially reduce the risk of acute episodes, which can have serious, even life-threatening consequences.”
The Lokelma clinical trials programme included three double-blinded, placebo-controlled trials and one open-label trial, where patients with hyperkalaemia were treated for up to 12 months.
Those trials showed that for patients receiving Lokelma, the median time to achieving normal potassium levels in the blood was 2.2 hours, with 98% achieving normal levels within 48 hours from baseline.
Lokelma also demonstrated a rapid reduction of potassium in the blood as early as one hour with one dose, and a sustained treatment effect for up to one year.
AstraZeneca said Lokelma was well tolerated, with “few” serious adverse events.
Lokelma is approved in the US, the EU and Canada for the treatment of hyperkalaemia, and was undergoing separate regulatory review in Japan, with a decision expected in the first half of 2020.
At 0939 GMT, shares in AstraZeneca were down 1.78% at 7,563p.