United Kingdom-based AstraZeneca has received recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its Forxiga (dapagliflozin) intended to treat adults with type-1 diabetes, it was reported yesterday.
The CHMP's positive opinion for the marketing authorisation of the product is for use as an oral adjunct treatment to insulin in adults with type-1 diabetes. Forxiga is a selective sodium glucose cotransporter-2 (SGLT2) inhibitor and is claimed to be the first oral medicine to receive a positive recommendation from the European Medicines Agency for use in type-1 diabetes as an adjunct to insulin in patients with BMI of up to 27 kg/m².
The recommendation is based on date from the phase III dapagliflozin assessment in patients with inadequately controlled type 1-diabetes (DEPICT) clinical program. The DEPICT clinical program covers two trials, including DEPICT-1 and DEPICT-2, with the primary efficacy endpoint at 24 weeks and long-term extension up to 52 weeks. The company stated that 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.
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