AstraZeneca's Forxiga receives approval in Japan for type-1 diabetes.
M2 PHARMA-March 28, 2019-AstraZeneca's Forxiga receives approval in Japan for type-1 diabetes
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AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, announced on Wednesday the approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) of Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D).
According to the company, this approval of Forxiga in Japan means that people with type-1 diabetes whose glucose levels are not adequately controlled with insulin alone now have a new oral treatment option available to them. Forxiga will help address a significant unmet need in this patient population.
Reportedly, this approval is based on data from the phase III DEPICT clinical programme and a dedicated trial in Japanese patients (D1695C00001). Results showed that Forxiga, when given as an oral treatment in addition 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 weeks1,2,3, at both 5mg and 10mg doses.
Also, the safety profile of Forxiga in these T1D trials was consistent with its well -established profile in type-2 diabetes (T2D), with the exception of a higher number of diabetic ketoacidosis (DKA) events in Forxiga-treated patients versus placebo. DKA is a known complication for adults with T1D that affects those with T1D more frequently than with T2D.
Forxiga is already indicated as a monotherapy and as part of combination therapy in adults with T2D to improve glycaemic control as an adjunct to diet and exercise.
Forxiga was approved by the European Commission on 20 March 2019 as an adjunct treatment to insulin in adults with T1D. It is under regulatory review in the US for the same indication, with a decision expected in the second half of 2019.
AstraZeneca is focused on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.
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|Date:||Mar 28, 2019|
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