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首页 » 医药产业 » 武田糖尿病药物NESINA获CFDA颁发进口药品注册证

武田糖尿病药物NESINA获CFDA颁发进口药品注册证

来源:生物谷 2013-07-31 15:26

2013年7月31日讯 /生物谷BIOON/ --武田(Takeda)及全资子公司武田-中国(Takeda (China) Holdings)今天宣布,2型糖尿病药物NESINA(alogliptin)已获得了中国国家食品药品监督管理局(CFDA)颁发的进口药品注册证(IDL)。

NESINA是一种口服二肽基肽酶-4抑制剂(DPP-4i),旨在减缓肠促胰岛素激素(incretin hormones)GLP-1(胰高血糖素样肽-1)和GIP(葡萄糖依赖性促胰岛素多肽)的失活,从而增加活性肠促胰岛素的总量,使胰脏以一种葡萄糖依赖的方式分泌胰岛素,从而协助管理血糖水平。该药最初由武田全资子公司Takeda California研发。(生物谷Bioon.com)

英文原文:Takeda Pharmaceutical Company Limited : Takeda Receives Marketing Authorization from China's CFDA for New Type 2 Diabetes Therapy NESINA (alogliptin)

Osaka, Japan, and Shanghai, China, July 31, 2013 - Takeda Pharmaceutical Company Limited (TSE: 4502, "Takeda") and its wholly-owned subsidiary, Takeda (China) Holdings Co., Ltd. today announced that the China Food and Drug Administration (CFDA) has issued an Import Drug License (IDL) for NESINA (alogliptin) for the treatment of type 2 diabetes.

NESINA 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 levels1. NESINA was originally created by Takeda California, Inc., Takeda's wholly-owned subsidiary located in San Diego, California.

"We are pleased with the CFDA approval of NESINA for the treatment of type 2 diabetes. It is an important milestone for the company and very good news for diabetes patients in China, and also for doctors who now have a new treatment that helps address the needs of their patients," said Haruhiko Hirate, Corporate Officer and Head of North Asia at Takeda. "Diabetes has become a rapidly growing public health problem inChina. Takeda has built a strong foundation in and maintained a robust focus on diabetes over the past 20 years, and remains committed to developing a diverse range of innovative products for the growing type 2 diabetes population."

Takeda has conducted extensive clinical research around NESINA, including placebo- and active-controlled clinical trials worldwide involving more than 13,000 patients2.

On June 23, Takeda presented new data from ENDURE (Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide Over 2 Years When Used in Combination with Metformin) study at the American Diabetes Association (ADA) Scientific Sessions. The data from ENDURE showed that the efficacy of alogliptin was sustained for two years in patients with type 2 diabetes, with notably less hypoglycemic episodes and no negative impact on weight compared with glipizide3.

In a multicenter, randomized, double-blind, placebo-controlled, phase 3 study conducted in mainland China, Taiwan and Hong Kong evaluating the safety and efficacy of alogliptin in patients with type 2 diabetes, alogliptin 25mg tablet, taken once daily, significantly reduced HbA1c and FPG compared to placebo when used as monotherapy, add-on to ongoing metformin or add-on to pioglitazone therapy (with or without metformin). Alogliptin also showed a safety profile comparable to placebo4.

Professor Changyu Pan, Chief Physician in the Department of Endocrinology, Chinese PLA General Hospital, and lead investigator in the study, commented, "China is seeing a rapid increase in the prevalence of diabetes according to several reports. Even though a variety of drugs are available, many patients still fail to achieve treatment goals. Intensive diabetes therapy can improve the success rate, however, the associated increased frequency of hypoglycemic episodes and weight gain still remain the common clinical challenges. The introduction of alogliptin provides physicians with a new treatment option to help patients meet their treatment goals."

NESINA was approved and launched in Japan in 2010, where Takeda has gained a wealth of post-marketing data surrounding this therapy in an Asian population. It is now available in the United States as a monotherapy and also in fixed-dose combinations with metformin (KAZANO) and pioglitazone (OSENI). These medications were approved by the U.S. Food and Drug Administration (FDA) in January 2013 for the treatment of type 2 diabetes in adults, as adjuncts to diet and exercise.

In China, rapid economic development has brought mass urbanization, changing diets and increasingly sedentary lifestyles. These factors greatly increase the risk of developing type 2 diabetes. China has the largest number of people with diabetes compared to any other country, with approximately 92.3 million adults suffering from the disease, 58.5% of which are undiagnosed. By 2030, an additional 37.4 million Chinese adults are expected to develop type 2 diabetes5.

In April 2013, Takeda entered an agreement with Sanofi to co-promote alogliptin in China to expand its reach to Chinese physicians treating patients with type 2 diabetes. Takeda and Sanofi teams in China are preparing for the launch of NESINA, to ensure that this important medicine reaches to type 2 diabetes patients as soon as possible.

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