Bristol-Myers Squibb and AstraZeneca have announced that the European Commission has approved Forxiga ( Dapagliflozin ) tablets for the treatment of type 2 diabetes in the European Union ( EU ).
Dapagliflozin is a selective and reversible inhibitor of sodium-glucose cotransporter 2 ( SGLT2 ) that works independently of Insulin to help remove excess glucose from the body, a unique mode of action not seen in any other currently available treatments for type 2 diabetes.
This is the first medicine in the new SGLT2 class to gain regulatory approval for the treatment of type 2 diabetes.
Forxiga tablets are indicated as a once-daily oral medication to improve glycaemic control in adult patients with type 2 diabetes. Forxiga is intended to be used as an adjunct to diet and exercise in combination with other glucose-lowering medicinal products, including Insulin, or as a monotherapy in Metformin-intolerant patients.
Dapagliflozin works in the kidney to selectively inhibit SGLT2, resulting in the removal of excess glucose and its associated calories in the urine. Through the removal of excess glucose, Dapagliflozin helps to reduce blood sugar levels.
The approval of Forxiga in the European Union is based on the results of a broad clinical development programme that included 11 double-blind, randomised, placebo-controlled Phase III clinical trials assessing the safety and efficacy of Forxiga as a once-daily oral therapy. These 11 trials involved 5,693 patients worldwide with type 2 diabetes, including 3,939 patients treated with Forxiga.
A higher proportion of patients with type 2 diabetes treated with Forxiga compared to placebo achieved the goal of HbA1c less than 7%.
The extensive clinical development programme also demonstrated that Forxiga had a positive benefit-risk profile, with a low risk of hypoglycaemia, across a wide range of patient populations.
Researchers also found additional benefits, such as reductions in body weight and systolic blood pressure in double-blind, randomised, placebo-controlled clinical trials.
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. 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.
Source: Bristol-Myers Squibb, 2012