The approval by the European Commission was based on a 24-week late-stage study that showed adding insulin to Onglyza significantly reduced blood sugar levels compared with the placebo added to insulin.
“Since many patients with type-2 diabetes eventually require insulin, it is important that anti-diabetic treatments can be used with insulin to help patients who are inadequately controlled on their current regimen to reach their treatment goals,” said Dr. Brian Daniels, senior vice president of global development and medical affairs at Bristol-Myers Squibb.
The companies warned Onglyza should not be used in patients with type-1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
As of September, AstraZeneca and Bristol had Onglyza submitted for regulatory approval in more than 90 countries. It is currently approved in 68, including the U.S., Canada, Mexico, India, China and 30 European countries.
Meanwhile, the European Commission also approved Novartis’ (NYSE:NVS) blood pressure treatment, Rasitrio, the company said on Monday. The drug is already approved in the U.S. under the name Amturnide.
The Swiss drugmaker said the newly approved drug combines three pills that all help lower blood pressure by helping the blood flow through vessels more easily.
Drugs in the combined pill include Rasilez, which inhibits enzyme produced by the kidneys that can narrow blood vessels; amlodipine, which relaxes blood vessel walls; and hydrochlorothiazide, which increases sodium chloride and water excretion.
In a statement, Novartis said the triple-combined drug provides a more convenient solution to the 85% of patients that may need multiple medications to help control their high blood pressure.