(dailyRx News) Before diabetes patients have access to a new drug, that drug has to go through an in-depth approval process. While one drug didn’t make the cut in the United States, Europeans now have a new diabetes drug option.

European regulators have approved a new drug to control blood sugar levels in people with type 2 diabetes.

The drug – called Forxiga (dapagliflozin) – is the first of a new class of drugs to be approved for use by patients.

Forxiga is part of a new class of drugs that work in the kidney to block a protein called SGLT2. By blocking this protein, the drug can remove excess glucose (sugar) and calories in the urine, which then helps lower blood sugar levels.

Forxiga – which is marketed by Bristol-Myers Squibb and AstraZeneca – is an oral drug taken once a day. It is meant to be used along with diet and exercise and with other blood sugar medications. Forxiga may also be used alone in patients who did not respond well to metformin – the most commonly used diabetes drug.

“Many Europeans with type 2 diabetes are not reaching treatment goals, increasing their risk of developing complications, so there is a critical need for new treatments,” said John Wilding, DM, FRCP, Professor of Medicine at the University Hospital Aintree in the United Kingdom.

According to Dr. Wilding, Forxiga gives doctors a new option to help their patients improve blood sugar control.

“The approval of Forxiga represents a significant advance in the treatment of type 2 diabetes,” he said.

Last January, the U.S. FDA rejected Forxiga due to concerns about the risk of cancer and liver injury. The FDA asked the drug-makers to do more research before the drug could be approved.

While Forxiga is not yet available to diabetes patients in the U.S., Bristol-Myers and AstraZeneca are working with FDA officials to make sure the FDA has all the data it needs to approve the drug.

“We are looking forward to getting approvals everywhere, and that includes with the FDA,” Fred Fiedorek, cardiovascular head at Bristol-Myers, told Reuters.

Research also showed that Forxiga may reduce weight and lower blood pressure – two main concerns in patients with type 2 diabetes.

“No other oral diabetes drug also lowers blood pressure and induces weight loss,” said Elisabeth Bjork, head of cardiovascular medicine at AstraZeneca, in an interview with Reuters.

The overall incidence of adverse events in patients treated with Forxiga 10 mg was similar to placebo. Few adverse events led to discontinuation of treatment and incidences were balanced across study groups. The most commonly reported events leading to discontinuation in patients treated with Forxiga 10 mg were increased blood creatinine (0.4%), urinary tract infections (0.3%), nausea (0.2%), dizziness (0.2%) and rash (0.2%). Vulvovaginitis and balanitis were more common with Forxiga™ (dapagliflozin). Most episodes of vulvovaginitis and balanitis were mild to moderate, responded to standard treatment, and rarely resulted in discontinuation from Forxiga treatment. The most frequently reported adverse reaction was hypoglycaemia, which was affected by the type of background therapy used in each study. Thus, Forxiga treatment led to higher rates of hypoglycaemia compared to placebo primarily when used in addition to background insulin or sulphonylurea therapies. However, Forxiga used as monotherapy or in combination with metformin did not demonstrate a tendency to cause hypoglycaemia, and the frequency of hypoglycaemia events with Forxiga in these settings was similar to placebo.

Use of the drug in clinical trials was also associated with about a 2 to 3 percent decline in body weight, as well as declines in systolic blood pressure.