6th Jan 2020 08:04
(Alliance News) - AstraZeneca PLC on Monday reported regulatory progress for two of its programmes, with Lokelma approved in China for the treatment of hyperkalaemia and Farxiga granted a priority review by the US Food & Drug Administration.
Lokelma was approved by the National Medical Products Administration, based on positive results from the clinical trial programme and a pharmacodynamic study, showing that patients receiving the product experienced a sharp, sustained reduction of potassium in the blood.
Lokelma is used to treat hyperkalaemia, which is characterised by high levels of potassium in the blood and can lead to cardiac arrest and death, if not treated quickly.
Lokelma is already approved in the US, EU and Canada, and is currently going through a separate regulatory review in Japan, with a decision expected in the first half of 2020.
"This approval marks an important milestone for more than two million patients in China who suffer from hyperkalaemia. 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," said Mene Pangalos, executive vice president for Biopharmaceuticals R&D.
Turning to the US, the Food & Drug Administration had accepted a supplemental new drug application for AstraZeneca's Farxiga, and also granted the product a priority review for reducing the risk of death in patients with heart failure with reduced ejection fraction.
The new drug application was based on results from the phase III DAPA-HF trail publishing in September 2019, which demonstrated that Farxiga reduced the outcome of heart failure worsening, compared to placebo.
The Prescription Drug User Free Act date, which is the FDA's action date for the supplemental application, has been scheduled for the second quarter of 2020.
"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. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure," Pangalos added.
AstraZeneca shares in London opened 0.9% lower at 7,650.00 pence each on Monday.
By Dayo Laniyan; [email protected]
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