Asian Scientist (Aug. 6, 2013) – The China Food and Drug Administration (CFDA) has issued an Import Drug License (IDL) for Takeda’s type 2 diabetes drug NESINA (alogliptin).
NESINA was originally created by Takeda California, Inc., Takeda’s wholly-owned subsidiary located in San Diego, California.
It is an orally-administered dipeptidyl peptidase-4 inhibitor (DPP-4i) designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels.
Takeda has conducted extensive clinical research around NESINA, including placebo- and active-controlled clinical trials worldwide involving more than 13,000 patients. The drug was approved and launched in Japan in 2010 and it is now available in the United States as a monotherapy and also in fixed-dose combinations with metformin (KAZANO) and pioglitazone (OSENI).
In April 2013, Takeda entered an agreement with Sanofi to co-promote alogliptin in China. Both teams are now preparing for NESINA’s launch in China.
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