Thursday, February 28, 2013

Dainippon Sumitomo receives approval for Surepost in combination with biguanides and thiazolidenediones

Dainippon Sumitomo Pharma Co., Ltd. has received approval for “SUREPOST® tablet 0.25 mg” and “SUREPOST ®tablet 0.5 mg” (generic name: repaglinide), a rapid-acting insulinsecretagogue, for the additional indications of combination therapy with biguanides and combination therapy with thiazolidinediones in Japan as of February 28, 2012. SUREPOST is a rapid-acting insulin secretagogue that stimulates postprandial insulin secretion by acting on the sulfonylurea receptor in pancreatic beta cells, thereby ameliorating postprandial blood glucose and lowering HbA1c in type 2 diabetes patients.

About Repaglinide

Repaglinide is approved and marketed in over 90 countries worldwide, under the brand name “Prandin ® ” in the United States and “NovoNorm ® ” in European countries. The drug generates about $500m in worldwide sales. 

In Japan, DSP took over development of the drug from Novo Nord isk A/S and continued clinical studies, then in January 2011 received manufacturing and market ing approval for the drug under the brand name SUREPOST ® as monotherapy as well as in combination with alpha-glucosidase inhibitors. SUREPOST ®was launched by DSP in May 2011. In Phase 3 clinical studies in Japan invo lving patients with type 2 diabetes who showed insufficient glycemic control even with the administration of bi guanide (metformin) or thiazolidinedione (pioglitazone), both of the SUREPOST ®combination arms ameliorated postprandial blood glucose and showed a significant difference in the primary endpoint of lowering HbA1c levels compared to the placebo combination arm, demonstrating the safety and efficacy of the drug.

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