2015年4月15日讯 /生物谷BIOON/ --FDA专家委员会在周二举行会议，对阿斯利康糖尿病药物Onglyza和武田的糖尿病药物Nesina的长期安全数据进行讨论。该委员会一致投票认为，应该对这2个药物的处方标签更新，纳入心脏衰竭风险。
专家委员会审查发现，Onglyza和Nesina都没有增加心血管死亡、中风或心脏发作的风险。但数据显示，Onglyza与统计学显著升高的心脏衰竭风险相关，Nesina也表现出升高的心脏衰竭风险，但未达到统计学显著差异。
该委员会部分成员表示，尽管Nesina所观察到的心脏衰竭风险是温和的，但他们怀疑这可能是所有DPP-4抑制剂类药物共有的风险，因此值得将这2种药物添加心脏衰竭风险信息。不过，专家委员会没有建议限制Onglyza或Nesina的处方。
阿斯利康Onglyza、武田Nesina与默沙东的Januvia同属于DPP-4抑制剂类药物，后者的长期安全数据预计在6月份公布。FDA专家委员会意见发布后，阿斯利康在美国的股价上涨3.2%，武田股价收盘下跌0.67%，默沙东股价上涨1.8%。
有分析师认为，由于Onglyza或Nesina均不存在严重的安全性问题，因此不会对当前的处方趋势带来实质性影响，DPP-4抑制剂类降糖药的销售很可能继续保持增长。
上周五，FDA发布了初步审查意见，发现Onglyza全因死亡率升高。专家委员会对这一问题的反应较为温和，该委员会认为，死亡的原因是多方面的，而且糖尿病患者本身容易患心脏疾病，因此难以评估这一风险是否真实存在或者只是统计上的一个巧合。
FDA在做出最终审查决定时，没有义务遵循其专家委员会的建议，但通常都会这么做。
英文原文：FDA panel backs safety updates for AstraZeneca, Takeda drugs
(Recasts, updates with details from Takeda review)
By Toni Clarke
WASHINGTON, April 14 (Reuters) - AstraZeneca Plc's diabetes drug Onglyza and Takeda Pharmaceutical Co.'s rival product Nesina should carry information about the risk of heart failure, an advisory committee to the U.S. Food and Drug Administration said on Tuesday.
Heart failure is a condition in which the heart cannot pump enough blood to meet the body's needs. It can be caused by coronary artery disease, high blood pressure, diabetes or obesity, according to the Mayo Clinic.
The panel reviewed safety data on AstraZeneca's Onglyza and Takeda's Nesina. The drugs belong to a class known as DPP-4 inhibitors which also includes Merck & Co.'s Januvia. Januvia data from a trial known as TECOS will be presented at a scientific meeting in June.
The studies were requested by the FDA as part of a broader investigation into the safety of diabetes drugs. In December 2008, the agency issued guidance requiring companies to conduct studies to show the drugs did not increase cardiovascular risk.
The panel found that neither Onglyza nor Nesina increased the risk of cardiovascular death, stroke or heart attack. But data showed a statistically significant increase in the risk of heart failure with Onglyza and an increased risk with Nesina that did not reach statistical significance.
Some panelists said that even though the heart failure risk seen with Nesina was modest, they suspect the risk will turn out to be a DPP-4 class effect and therefore worth including.
The panel did not recommend any restrictions on prescribing the drugs. AstraZeneca's U.S. shares rose 3.2 percent. Takeda's shares closed down 0.67 percent before the vote was announced. Merck's shares rose 1.8 percent.
"Given the absence of a serious safety issue for either Onglyza or Takeda's Nesina suggests that, barring an overtly negative signal in TECOS, growth of the DPP-4 class is likely to continue without a meaningful change in current prescribing trends," Leerink analyst Seamus Fernandez said in a research note.
A preliminary FDA review of Onglyza published on Friday found an increase in the rate of death from all causes. Panel members said they were moderately concerned about the signal but said their concern was muted by the fact that the causes of death were varied and lacked any common theme.
Onglyza, known also as saxagliptin, was approved in 2009. Nesina, or alogliptin, was approved in 2013. The FDA is not obliged to follow the advice of its advisory panels but typically does so.
(Reporting by Toni Clarke; Editing by Will Dunham and Andrew Hay)