Astellas Secures Approval For Diabetes Drug Suglat In Japan
Astellas Pharma announced it has secured marketing approval for its diabetes drug Suglat in Japan. The company originally filed for approval in March of 2013.
Suglat (generic name Ipragliflozin L-Proline) is a selective sodium-glucose co-transporter 2 (SGLT2) indicated in treatment of type 2 diabetes. SGLTs are existing membrane proteins found on cell surfaces which transfer glucose into the cell. SGLT2 is a subtype of SGLT which plays a critical role in glucose reuptake in the kidneys’ proximal tubule.
The drug works by reducing glucose levels in the blood through inhibition of glucose reuptakes. Suglat selectively targets inhibiting SGLT2 membrane proteins on cell surfaces. When used in combination with other hypoglycemic agents (six types) available in Japan during the Phase III monotherapy and clinical trial studies, the drug continued to exhibit efficacy and safety for use.
Siglat is the first SGLT2 inhibitor approved as a type 2 diabetes treatment in Japan. Its novel mechanism of SGLT action makes it unique as an oral hypoglycemic agent for type 2 diabetes treatment. Type 2 diabetes is also known as non-insulin-dependent diabetes mellitus or adult onset diabetes. The disease is characterized by high glucose due to insulin resistance and relative deficiency in insulin. Patients with type 2 diabetes typically require anti-diabetic agent treatment regimens to regulate blood glucose levels.
With Suglat’s approval, Astellas expects to supply additional therapeutic options for treatment of type 2 diabetes in the Japanese market. A recommended once-daily dosage regimen of 50mg to 100mg for adults is advised based on careful observation of the disease progress. Suglat is available in 25mg and 50mg tablets.
Astellas developed Suglat together with Kotobuki Pharmaceutical. The company will manufacture and market Suglat in the country while its partners, Kotobuki Pharmaceutical and MSD K.K., will co-promote the drug.
Source:
http://www.astellas.com/en/corporate/news/detail/approval-of-suglat-tablets-a-s.html