TrialWatch: Based on DEPICT 1 &2 AstraZeneca’s Forxiga Recommended for EMA Approval

Feb 5, 2019 | Dapagliflozin, Diabetes Type 1, Diabetes Type 2, EMA Approval, Europe, Farxiga, Positive Results

Diabetes Type 1

Pharmaceutical Business Review reports that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended AstraZeneca’s Forxiga (dapagliflozin) to treat adults with type 1 diabetes.  TrialSite News has covered this drug in past writings.

Dapagliflozin is called Farxiga in the U.S. and Forxiga in the EU and Russia. It falls in the gliflozin class of drug and is used to treat type 2 diabetes. Co-developed by Bristol-Myers Squibb and AstraZeneca, the FDA first approved the drug January 2014 for glycemic control, along with diet and exercise in adults with type 2 diabetes. SGLT2 inhibitors, including dapagliflozin, reduce the likelihood of hospitalization for congestive heart failure or progression of renal disease in persons with type 2 diabetes and reduce the likelihood of stroke and heart attack in persons with type 2 diabetes who have known atherosclerotic vascular disease.

The drug has also been approved by the FDA in combination with metformin hydrochloride extended release—known as Xigduo XR in November 2014. By February 2017, the FDA approved the drug as a once-daily combination with saxagliptin mg as Qtern.  Dapagliflozin was subject to a pharmacoeconomic analysis from a UK health system perspective. The authors concluded that dapagliflozin represented the first-in-class selective SGLT2 inhibitor licensed in Europe. Clinical trials evidenced it had an effect on HbA1c comparable with existing treatments and a superior outcome in terms of weight reduction.  These authors argued the drug is cost-effective within acceptable UK thresholds for treatments of patients with type 2 diabetes.

The most recent European recommendation arises out of the DEPICT clinical program which included two trials—DEPICT-1 and DEPICT-2. 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


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