The European Commission has granted marketing authorisation for Empagliflozin ( Jardiance ), a sodium glucose cotransporter 2 ( SGLT2 ) inhibitor.
Empagliflozin has been approved for the treatment of type 2 diabetes to improve glycaemic control in adults.
The European Commission approved Empagliflozin 10 and 25 mg once daily tablets for use when diet and exercise alone do not provide adequate glycaemic control: a) alone when Metformin is not considered appropriate due to intolerance; b) alongside other glucose-lowering medicines including insulin when glucose control is inadequate.
The phase III clinical trial programme that supported Empagliflozin’s marketing authorisation enrolled over 13,000 patients. Results from the programme showed Empagliflozin 10 and 25 mg provided a significant reduction in blood sugar from baseline values.
Both Empagliflozin groups also demonstrated clinically relevant reductions from baseline values in body weight and blood pressure.
When used as monotherapy, most adults did not experience side effects such as weight gain, low blood sugar and gastrointestinal issues.
Common side effects experienced with Empagliflozin were genital infection, urinary tract infection and increased urination. Genital infection and urinary tract infection were more common in women than men.
Empagliflozin is an oral, once daily tablet for the treatment of adults with type 2 diabetes and is part of the SGLT2 inhibitor class. SGLT2 are proteins fundamental to the kidney’s role in filtering blood sugar and are responsible for about 90% of the reabsorption of glucose back into the bloodstream.
In people with type 2 diabetes mellitus, there is an overexpression of SGLT2, contributing to elevated blood glucose levels.
Empagliflozin reduces the kidneys’ ability to reabsorb glucose into the bloodstream, leading to urinary glucose excretion.
Unlike most classes of existing oral antidiabetics, SGLT2 inhibitors like Empagliflozin work independently of beta-cell function and insulin pathway. ( Xagena )
Source: Boehringer-Ingelheim, 2014