European Commission approves AstraZeneca's Forxiga.
M2 PHARMA-March 27, 2019-European Commission approves AstraZeneca's Forxiga
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The European Commission (EC) has approved United Kingdom-based AstraZeneca's Forxiga (dapagliflozin) for use in type-one diabetes (T1D) as an adjunct to insulin in patients with a BMI of less than 27kg/m2, when insulin alone does not offer adequate glycaemic control despite optimal insulin therapy, it was reported yesterday.
This is the first approval of the product intended for the treatment of patients with type-one diabetes.
The product has received approval 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, indicated that Forxiga 5mg daily, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled type-1 diabetes, 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.
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|Date:||Mar 27, 2019|
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