AstraZeneca diabetes drug gets FDA approval
AstraZeneca said that the US Food and Drug Administration has approved a new formulation of its type-2 diabetes treatment Bydureon.
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The FDA has approved Astra’s injectable suspension, a new formulation in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycaemic control.
Bydureon BCise has a unique, continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the active ingredient, exenatide, to help patients reach and maintain steady state. The new formulation in the Bydureon BCise device is proven to reduce blood sugar levels, with the added benefit of weight loss.
Also on Monday, the FTSE 100 pharmaceuticals group said that it and Merck & Co have submitted a new drug application to Japan's Pharmaceuticals and Medical Devices Agency for the use of Lynparza tablets in unresectable or recurrent BRCA-mutated breast cancer, with a decision expected in the second half of 2018.
The Japan NDA is based on the positive results from the Phase III Olympiad trial published in the New England Journal of Medicine.