LONDON (dpa-AFX) - AstraZeneca Plc (AZN.L, AZN) said that the European Commission has approved Forxiga (dapagliflozin) for use in type-1 diabetes or T1D as an adjunct to insulin in patients with a BMI - 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy. This is the first approval of Forxiga for the treatment of patients with T1D.
The approval is based on data from the Phase III DEPICT clinical programme for Forxiga in T1D. The short-term (24 week) and long-term (52 week) data from DEPICT-1, along with the short-term data from DEPICT-2, showed that Forxiga 5mg daily, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, demonstrated significant and clinically-meaningful reductions from baseline in average blood glucose levels HbA1c (primary endpoint), weight and total daily insulin dose (secondary endpoints) at 24 and 52 weeks.
Forxiga is currently under regulatory review in Japan and the US for use as an adjunct treatment to insulin in adults with T1D, with a decision expected in the first and second half of 2019, respectively.
Copyright RTT News/dpa-AFX
© 2019 AFX News
