21st May 2018 08:36
LONDON (Alliance News) - Drugmaker AstraZeneca PLC said Monday the US Food & Drug Administration approved the company's hyperkalaemia drug Lokelma.
Lokelma, formerly known as ZS-9, is used to treat adults with hyperkalaemia, a condition characterised by elevated potassium levels in the blood, associated with cardiovascular, renal and metabolic diseases.
The FDA approval follows three double-blind, placebo controlled trials and two open label clinical trials providing data to support the efficacy of the drug.
"We are pleased by today's FDA approval of Lokelma as it enables us to help address a long-standing clinical need with a new medicine that offers rapid and sustained treatment for adults with hyperkalaemia," Sean Bohen AstraZeneca executive vice president, global medicines development and chief medical officer said.
Separately, the pharmaceutical company said it has submitted a supplemental new drug application to Japan's Pharmaceuticals & Medical Devices Agency for the use of Forxiga, a drug used in the treatment of adults with type-1 diabetes.
Foxega, which is also under regulatory review in Europe, is a selective sodium-glucose co-transporter 2 inhibitor as an oral adjunct treatment to insulin.
Japan's submission follows data from DEPICT, a clinical programme for Foxega, and a dedicated trial on Japanese patients showing "clinically-meaningful" results.
AstraZeneca shares were trading up 1.8% early Monday morning at 5,337.00 pence.
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