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FDA打消对默沙东糖尿病新药Januvia的安全性忧虑

  1. FDA
  2. Januvia
  3. 默沙东

来源:生物谷 2013-08-04 22:33

2013年8月3日讯 /生物谷BIOON/ --FDA今日表示其对默沙东公司研制的糖尿病新药Januvia的安全性表示放心。Januvia是一种肠促胰岛素类似物类药物,能够有效调控糖尿病患者的血糖浓度,但是其安全性隐患一直困扰着默沙东公司。同为该类药物的还有诺和诺德公司的Victoza以及施贵宝和阿斯利康的Onglyza和Byetta。 FDA是在上周对该类药物的安全性作出如上评论的。

2013年8月3日讯 /生物谷BIOON/ --FDA今日表示其对默沙东公司研制的糖尿病新药Januvia的安全性表示放心。Januvia是一种肠促胰岛素类似物类药物,能够有效调控糖尿病患者的血糖浓度,但是其安全性隐患一直困扰着默沙东公司。同为该类药物的还有诺和诺德公司的Victoza以及施贵宝和阿斯利康的Onglyza和Byetta。

FDA是在上周对该类药物的安全性作出如上评论的。(生物谷Bioon.com)

详细英文报道:

Merck ($MRK) can relax now. The FDA says it's not worried about a new study linking pancreatitis with the company's big diabetes drug Januvia and other drugs in its category. The group of drugs, known as incretin mimetics, was cleared last week by the FDA's counterparts in Europe.

The FDA tells Pharmalot that it concurs with the EMA's conclusions about the drugs and sees no need to change the official labeling about potential safety risks, at least right now. "FDA's review is ongoing as pancreatitis and pancreatic cancer data are being collected" in ongoing outcomes trials looking at the drugs' impact on cardiovascular health in diabetics, an agency spokeswoman told Pharmalot.

The list of incretin mimetic drugs includes a handful of therapies besides Januvia, including Novo Nordisk's ($NVO) blockbuster Victoza and Bristol-Myers ($BMY) and AstraZeneca's ($AZN) Onglyza and Byetta. But the safety worries have been a drag on Merck's stock, especially considering the company's reliance on Januvia sales as it suffers from generic rivals to its once-top-selling Singulair. ISI Group analyst Mark Schoenebaum called the safety worries "one of the key overhangs" on Merck's stock. Now that the FDA has spoken, he said in a note this morning, "I would view this overhang as largely dead."

The FDA has already flagged worries about pancreatitis on Januvia and Byetta's labels, so the questions aren't entirely new. But the latest debate over potential links between these meds and pancreatitis and, in turn, pancreatic cancer, began earlier this year, with a new study that analyzed insurance records to find that patients hospitalized with pancreatitis were twice as likely to be using Januvia or Byetta, compared with diabetes patients who didn't have pancreatitis. It appeared to be a clearer association than previous reports had shown.

The EMA said its experts dug into the data and found "methodological limitations and potential sources of bias" and decided the available data don't bear out worries about an increased risk of "pancreatic adverse events." The communique affected the entire group of incretin mimetics, which comprises GLP-1 agonists, which mimic a key hormone, and DPP-4 inhibitors, which interfere with a protein that breaks down the same hormone.

 

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