In a busy morning of announcements for AstraZeneca PLC (LON:AZN), Britain’s largest drugs group said it received regulatory sign-off for a blood drug in China while being granted a US priority review for a diabetes drug.
The latter first: the Food & Drug Administration said it will fast-track what’s called a supplemental review of Farxiga for people with heart failure. If the FDA gives the green light, it then broadens the scope and sales potential of the type-two diabetes treatment.
In a separate announcement, the company said the authorities in China had approved Lokelma for the patients with elevated levels of potassium in the blood, a condition called hyperkalaemia.
"This approval marks an important milestone for more than two million patients in China who suffer from hyperkalaemia,” said Mene Pangalos, head of biophmarmaceutical research at AZ.
“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."