FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Europe Approves AZ’s Forxiga Diabetes Treatment

April 2, 2019

The European Commission approved AstraZeneca’s type-1 diabetes drug Forxiga (dapagliflozin) as an adjunct treatment to insulin for certain patients.

The approval—Forxiga’s first for treating type-1 diabetes—applies to patients with a body mass index of at least 27 who don’t see their glucose levels controlled adequately by insulin therapy alone.

The Commission’s decision comes after its analysis of the company’s Phase III clinical trial data. The trial showed that five milligram daily dose of Forxiga as an oral adjunct gave clinically meaningful and significant reductions in average blood glucose levels, weight and total daily insulin dose at 24 and 52 weeks.

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