AstraZeneca and Bristol-Myers Squibb receive EU approval for diabetes drug use in kidney cases

March 9, 2011

AstraZeneca PLC and Bristol-Myers Squibb Co. say their diabetes drug Onglyza has been approved in Europe for treating people with Type 2 diabetes who have moderate or severe renal impairment.

The two companies said Friday that the approval from the European Commission makes Onglyza the first so-called DPP4 drug cleared for such purposes in Europe.

For its regular use, Onglyza has been submitted for regulatory review in almost 90 countries and is approved in 56 countries, including the United States, Canada, Chile, India, Brazil and 30 European countries.

The companies last month announced they were expanding the label of the drug in the United States to add information about its effects in patients with kidney failure after receiving approval from the Food and Drug Administration.

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