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Bristol-Myers Squibb and AstraZeneca’s Onglyza receives new EU approval
Bristol-Myers Squibb and AstraZeneca's diabetes therapy Onglyza has received European regulatory approval in a new specification.
The drug has been ratified by the European Commission for use in combination with insulin, either with or without metformin, as a means of improving glycaemic control among type 2 diabetes patients.
Approval was given based on positive data from phase IIIb clinical studies showing the safety and efficacy of the drug in regulating blood sugar levels, when compared to placebo.
This ruling is important due to the fact that many diabetes patients will require insulin treatment at some point, making it vital that any anti-diabetic therapies can accommodate this.
Dr Howard Hutchinson, chief medical officer for AstraZeneca, said: "The European approval of Onglyza as a combination therapy with insulin helps to advance treatment of type 2 diabetes by offering physicians another option to help patients manage this chronic and progressive disease."
This comes after Bristol-Myers Squibb also received EU approval for a labelling update for its HIV treatment Reyataz earlier this week.
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