Sanofi, Gilead get boosts in Japan with new Lantus & Harvoni approvals
- In Japan, roughly 9.5 million people have diabetes, while more than one million have chronic hepatitis C (HCV) infections.
- Approvals of Sanofi's Lantus XR and Gilead's Harvoni by Japan's Ministry of Health, Labor and Welfare (MHLW) are based on the strength of clinical data from trials conducted in Japan, as well as outside of Japan.
- These treatments have already been approved in both the U.S. and the E.U. and have been available to patients in these markets for some time.
Lantus is a good addition the list of available therapies for treatment of diabetes in Japan, because roughly 50% of patients with diabetes worldwide fail to achieve adequate blood sugar control. Sanofi's long-lasting insulin Lantus XR allows patients to be aggressive enough with dosing to achieve improved glycemic control, with less nocturnal hypoglycemia and no increase in hypoglycemia during the day.
With respect to Harvoni (ledipasvir/sofosbuvir), patients now have acess to a 12-week treatment option with a high cure rate for HCV genotype 1—which represents 70% to 80% of all infections.
- Pharma Times Sanofi's Lantus, Gilead's Harvoni welcomed to Japan