TOP NEWS: AstraZeneca Drug Forxiga Approved To Treat Type-1 Diabetes

LONDON (Alliance News) - AstraZeneca PLC on Monday said its drug Forxiga has been approved in ...

Alliance News 25 March, 2019 | 8:38AM
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LONDON (Alliance News) - AstraZeneca PLC on Monday said its drug Forxiga has been approved in Europe as a treatment for type-1 diabetes.

Forxiga has been approved to be taken orally, alongside insulin, in type-1 diabetic patients who cannot adequately control their blood glucose.

The approval by the European Commission was based on the results of the pharma major's phase-three Depict clinical programme for Forixga in type-1 diabetic patients.

Data from the study showed that Forixga reduced blood glucose levels on average, as well as reducing weight and total daily insulin dose.

"Forxiga is the first oral medicine approved in Europe as an adjunct to insulin for people living with type-1 diabetes whose glucose levels are not adequately controlled with insulin alone. We look forward to bringing Forxiga to a patient population that has not had any approved oral medicines available before," said Elisabeth Bjork, senior vice president & head of late Cardiovascular, Renal & Metabolism, R&D BioPharmaceuticals at Astra.

The drug is already approved for use in the treatment of type-2 diabetes and Forixga's safety profile in the type-1 diabetic trials was consistent with previous trials of Farixga in type-2 diabetics, although a condition called diabetic ketoacidosis was more likely to occur in type-1 diabetics than type-2 during trials.

Diabetic ketoacidosis is a serious complication of diabetes in which the body begins to break down fat, releasing harmful substances called ketones into the blood that can be life-threatening. It is more common in type-1 diabetics than type-2.

At present, Forixga is under regulatory review in both Japan and the US as an adjunct treatment to insulin in type-1 diabetic patients, with a decision expected in the first and second halves of 2019 respectively.

Type-1 diabetes is a chronic condition in which the pancreas produces either little or no insulin, with around 5% of diabetics having type-1. It is an autoimmune disease, resulting from the immune system attacking the cells in the pancreas that make insulin.

This differs from type-2 diabetes, where patients typically can produce insulin but their cells are less responsive to it.

Shares in AstraZeneca were trading flat at 6,350.00 pence on Monday morning.

By Anna Farley; annafarley@alliancenews.com

Copyright 2019 Alliance News Limited. All Rights Reserved.

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AstraZeneca PLC 7,217.00 GBX -0.80

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