The first oral medication for type 1 diabetes, to be taken alongside insulin, has been approved by the European Commission (EC).
The approval for Forxiga follows a positive recommendation, in February, from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
Forxiga (dapagliflozin), made by AstraZeneca, has shown to help improve blood glucose control in people with type 1 diabetes that have been unable to achieve good control on insulin alone.
Forxiga is a sodium-glucose co-transporter 2 (SGLT2) medication which works by encouraging the kidney to filter more glucose out of the blood than it would usually. The excess glucose is then excreted out of the body via the urine.
The approval was based on two major studies which monitored the drug’s outcomes for 24 weeks and a longer-period of 52 weeks.
The results of both the DEPICT-1 and DEPICT-2 trials showed that 5mg and 10mg of the oral medication significantly lowered people’s HbA1c levels without increasing risks of severe hypoglycemia.
However, Forxiga was associated with a greater risk of diabetic ketoacidosis (DKA) events. DKA is a serious diabetes complication that develops the body produces a very high level of ketones that causes the blood to turn acidic.
Within the DEPICT-1 and DEPICT-2 trials, roughly 1 in 50 people taking the drug developed DKA. The rate of DKA in those taking placebo ranged between no-one having DKA (in the DEPICT-2 trial) and around 1 in 90 (within the DEPICT-1 trial).
Elisabeth Björk, senior vice president, Head of late phase Cardiovascular and Metabolic development unit within AstraZeneca, said: “Forxiga is the first oral medicine approved in Europe as an adjunct to insulin for people living with type 1 diabetes whose glucose levels are not adequately controlled with insulin alone.”
Forxiga has been available for people with type 2 diabetes in the UK since May 2013.