来得时救星，赛诺菲新一代基础胰岛素Toujeo喜获FDA批准

法国制药巨头赛诺菲（Sanofi）近日收获重磅消息，该公司研发的来得时（Lantsu）升级产品Toujeo喜获FDA批准。来得时(Lantus)是全球首个长效胰岛素类似物，已在全球糖尿病市场称霸多年，该药是赛诺菲名副其实的摇钱树，年销售额高达80亿美元，其美国专利(5656722*PED)已于2015年2月12日到期。而此时Toujeo顺利拿到FDA批文，时机可谓真真儿好。赛诺菲已迫不及待计划于今年第二季度初迅速将Toujeo推向市场。

具体而言，FDA已批准Toujeo（甘精胰岛素[重组DNA来源]注射液，300U/mL）作为一种每日一次的长效胰岛素，用于1型和2型糖尿病成人患者，以改善血糖控制。Toujeo的获批，是基于EDITION临床项目的数据，该项目包括一系列国际III期研究，在更广泛和多样性糖尿病（1型和2型）群体中评估了Toujeo的疗效和安全性。该项目所有临床研究均达到了主要终点，数据显示，Toujeo降血糖疗效媲美来得时，同时低血糖（hypoglycemia）发生率显著降低。低血糖是胰岛素治疗中最可怕的副作用，可能导致患者晕倒或失去知觉。

Toujeo被认为是赛诺菲糖尿病管线中最重要的产品，而该公司也迫切希望在来得时美国专利到期之际，尽可能快地将来得时患者群体转向Toujeo，以稳固其市场霸主地位。另一方面，尽管业界已掀起来得时仿制热潮，且礼来的来得时仿制药Basaglar已上市欧盟，一场来得时大屠杀已拉开帷幕。但在美国市场，赛诺菲针对礼来的专利诉讼，成功将Basaglar美国上市上市时间推后30个月至2016年中。同时，礼来新一代基础胰岛素peglispro预计本季度才向FDA和欧盟提交监管申请，而诺和诺德新一代胰岛素Tresiba此前被FDA拒绝，预计也要到2016年才可能登录美国。因此，就目前局势而言，在美国糖尿病市场中，尚无人能挑战赛诺菲的霸主地位。

英文原文：

FDA approves Sanofi's diabetes drug Toujeo

(Reuters) - U.S. health regulators on Wednesday approved Sanofi's diabetes drug Toujeo, a more potent follow-up to the French drugmaker's top-selling insulin product Lantus.

The Food and Drug Administration approved the once daily, long-acting basal insulin to treat adults with both type 1 and the far more prevalent type 2 diabetes.

The medicine is considered among the most important in Sanofi's pipeline. The company is expected to try to convert patients from Lantus to Toujeo as quickly as possible, with the older drug about to lose U.S. patent protection.

Sanofi bought some time with a patent infringement lawsuit filed last year against Eli Lilly and Co that would keep a cheaper Lantus generic off the market for 30 months.

In addition gaining Toujeo patients through conversions, "there's about a million new patients for basal insulin each and every year," said Joe Balzer, head of U.S. commercial operations for Toujeo, which is awaiting a European approval decision.

Toujeo has the same active ingredient as Lantus, called insulin glargine, but at three times the concentration and with a design to release the insulin more gradually. The medicine provides similar blood glucose control as Lantus with significantly lower rates of hypoglycemia, a potentially dangerous drop in blood sugar.

Lantus, the world's most prescribed insulin with sales of $7.2 billion in 2014, accounts for more than 30 percent of Sanofi profit. Warnings of faltering U.S. Lantus sales contributed to the sudden sacking of Sanofi Chief Executive Officer Chris Viehbacher last year.

His successor, Olivier Brandicourt, is set to assume the top post on April 2, about the same time Sanofi plans to begin selling Toujeo.

The company has yet to announce a Toujeo price and declined to discuss any discounting strategy aimed at gaining reimbursement from insurers and other payers.

"We are confident of Toujeo achieving a position on payer formularies," said Andrew Purcell, head of Sanofi's U.S. diabetes business.

More than 370 million people worldwide have diabetes, according to the International Diabetes Federation. Some 90 percent to 95 percent have type 2, which is often associated with obesity and significantly raises the risk of numerous serious health problems. While most people with type 2 diabetes start with a variety of other medicines to control blood sugar, as the disease progresses many eventually require insulin.

(Reporting by Bill Berkrot in New York; Editing by Lisa Shumaker)