Januvia and Suglat combination filed for Japan approval

Astellas Pharma (TYO: 4503) says its partner, MSD KK, the Japanese subsidiary of US pharma giant Merck & Co (NYSE: MRK), has submitted an application for marketing approval of a combination drug of the DPP-4 inhibitor Januvia (sitagliptin) phosphate hydrate and the SGLT2 inhibitor Suglat (ipragliflozin L-proline) for the treatment of type-2 diabetes in Japan.

Merck’s Januvia is the first selective DPP-4 inhibitor in Japan manufactured and marketed by MSD. This once-daily inhibitor selectively inhibits DPP-4 and increases the active incretin levels, thus demonstrating glucose-dependent glucose-lowering effect. Suglatis the first selective SGLT2 inhibitor in Japan manufactured and marketed by Astellas.

The combination of these two drugs with different mechanisms of action for the treatment of type-2 diabetes is expected to reduce patients’ burden of taking drugs and improve their adherence. In a clinical study conducted to support this application, the drug has shown efficacy, safety and tolerability. The two companies started collaboration on the combination therapy in April 2015.