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.