The CHMP’s positive opinion for the marketing authorization of Forxiga is for use as an oral adjunct treatment to insulin in adults with T1D.
Forxiga, which is a selective sodium glucose cotransporter-2 (SGLT2) inhibitor, is claimed to be the first oral medicine to secure a positive recommendation from the EMA for use in T1D as an adjunct to insulin in patients with BMI ≥ 27 kg/m².
The recommendation is based on date from phase III dapagliflozin evaluation in patients with inadequately controlled type 1-diabetes (DEPICT) clinical program.
The DEPICT clinical program include two trials, comprising of DEPICT-1 and DEPICT-2, with the primary efficacy endpoint at 24 weeks and long-term extension up to 52 weeks.
According to the company, both studies showed that Forxiga when given as an oral adjunct to adjustable insulin in adults with inadequately-controlled T1D demonstrated significant reductions from baseline in HbA1c, weight and total daily insulin dose at 24 and 52 weeks against placebo at both 5mg and 10mg doses.
Forxiga is also being reviewed in the US and Japan for use as adjunct treatment to insulin in adults with T1D.
DEPICT-1 and DEPICT-2 are 24-week, randomised, double-blinded and parallel-controlled trials designed to evaluate the effects of Forxiga 5mg or 10mg on glycaemic control in patients with T1D inadequately controlled by insulin.
The company has assessed all patients at 24 and after a 28-week extension.
Forxiga is being assessed in clinical trial program, including 35 completed and ongoing phase IIb/III trials in more than 35,000 patients.
AstraZeneca cardiovascular, renal and metabolism, biopharmaceuticals head and vice president Elisabeth Björk said: “People with type-1 diabetes have not seen oral treatment innovation in decades and we believe today’s announcement signals an important advancement for them, as well as a broader understanding of the well-established clinical profile of Forxiga for people living with metabolic diseases.”