Forxiga sNDA approved in Japan for type-1 diabetes

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D), following a supplemental new drug application (sNDA) filing for the drug in May last year.

Elisabeth Björk, senior vice president, head of late cardiovascular, renal and metabolism, R&D BioPharmaceuticals, at Anglo-Swedish pharma major AstraZeneca (LSE: AZN) said: “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, and this approval in type-1 diabetes builds on the well-established clinical profile of Forxiga.”

Forxiga, which in 2018 generated revenues of $1.4 billion for AstraZeneca, was first approved in the European Union in November 2012 and in the USA in January 2014.