EC approves additional use for Bristol-Myers and AstraZeneca's Onglyza and Komboglyze
The European Commission has approved drug majors Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca’s (LSE: AZN) Onglyza (saxagliptin) for use as a combination therapy with insulin (with or without metformin) to improve blood sugar (glycemic) control in adult patients with type 2 diabetes.
It has also cleared the companies’ Komboglyze (saxagliptin and metformin HCl immediate-release fixed-dose combination). The indication for Komboglyze is as an adjunct to diet and exercise to improve glycemic control in adult patients aged 18 years and older with type 2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.
The news was welcomed by investors, as B-MS’s shares rose 2.8% to $31.01 and AstraZeneca advanced 3% to $43.80 in morning trading in the USA yesterday.
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