BRIEF—Regulatory submission in Japan for Forxiga in type 1 diabetes

AstraZeneca has submitted a supplemental new drug application (sNDA) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the use of Forxiga (dapagliflozin), a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, as an oral adjunct treatment to insulin in adults with type 1 diabetes (T1D).

The Japanese submission follows a European regulatory filing in March this year for use as an oral adjunct treatment to insulin in adults with T1D, the Anglo-Swedish pharma major noted.

The Japan sNDA is based on Phase III data from the DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes) clinical programme for Forxiga in T1D and a dedicated trial in Japanese patients (trial D1695C00001).

Results showed that Forxiga, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, demonstrated significant and clinically-meaningful reductions from baseline in HbA1c, weight and total daily insulin dose at 24 and 52 weeks, compared to placebo, at both 5mg and 10mg doses.

Forxiga, which in 2017 generated revenues of $1.1 billion for AstraZeneca, was first approved in the European Union in November 2012 and in the USA in January 2014.