FDA委员会建议批准GSK COPD新复方药Anoro

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2013年9月11日讯 /生物谷BIOON/ --9月10日，葛兰素史克（GSK）和Theravance制药联合宣布，FDA肺过敏药物顾问委员会（PADAC）以11:2的投票结果，建议批准新复方药Anoro ELLIPTA，作为每日一次的吸入性疗法，用于慢性阻塞性肺病（COPD）患者的长期维持治疗，包括慢性支气管炎和肺气肿。
Anoro ELLIPTA是实验性COPD新复方药物UMEC/VI（umeclidinium/vilanterol，62.5/25 mcg）的拟用商品名，该药为长效毒蕈碱受体拮抗剂（LAMA）UMEC和长效β2受体激动剂维兰特罗(VI)的复方药物，通过新型干粉吸入器ELLIPTA给药。
此外，FDA顾问委员会也一致认为Anoro的安全性数据已充分证明了62.5/25mcg剂量用于COPD的安全性（10:3），疗效数据也提供了充分的证据，证实了Anoro作为每日一次的吸入性疗法用于COPD气道阻塞长期维持治疗的临床益处（13:0）。
汤姆森路透分析师平均估计，Anoro ELLIPTA在2018年的销售额将超过20亿美元。
2012年12月，GSK向FDA提交了Anoro ELLIPTA的新药申请（NDA），该药的处方药用户收费法（PDUFA）目标日期为2013年12月18日，目前该药未获全球任何监管批准。
Anoro ELLIPTA是葛兰素史克的一个独特产品，如果获批，将是市场上首个LAMA/LABA组合，将与勃林格殷格翰（Boehringer Ingelheim）和辉瑞（Pfizer）的长效毒蕈碱受体拮抗剂（LAMA）思力华（Spiriva）竞争，Spiriva也被称为噻托溴铵，是市场上唯一销售的LAMA。
今年5月，FDA批准了葛兰素史克（GSK）与Theravance公司的一款COPD新复方药物Breo（美国以外的国家称为Relvar），该药为每日1次的吸入型糖皮质激素糠酸氟替卡松(FF)和长效β2受体激动剂维兰特罗(VI)的复方药物，分析师预计，该药在2018年的销售将达到19亿美元。（生物谷Bioon.com）
英文原文：FDA panel supports approval of Glaxo lung drug Anoro
WASHINGTON (Reuters) - A federal advisory panel recommended approval of GlaxoSmithKline's new drug to treat chronic obstructive pulmonary disease (COPD), and suggested the company be required to conduct further safety studies afterwards.
The panel of expert advisers to the U.S. Food and Drug Administration voted 11-2 to approve the inhalant drug, Anoro, to help improve lung function in people with the disorder often associated with smoking.
Anoro is a combination of vilanterol, which is designed to open the airways, and umeclidinium, which works to improve lung function. GSK is developing the product with partner Theravance Inc.
The FDA is not required to follow the advice of its advisory panels but typically does so.
The drug is expected to generate sales of more than $2 billion a year by 2018, six analysts polled by Thomson Reuters estimated on average. A decision is expected by December 18.
Much of the panel's discussion centered on the drug's safety profile, particularly an imbalance in the number of non-fatal heart attacks seen in patients taking Anoro in shorter clinical trials compared with those taking a placebo.
A similar imbalance was not seen in a longer safety study, however, leaving many panel members scratching their heads and worried that the drug may increase the risk of cardiovascular problems in sicker patients.
Dr. James Stoller, chair of the Education Institute at the Cleveland Clinic, said the data left him with a "non-specific sense of unease" and he voted against the drug.
Even some of those who voted in favor of the drug did so with hesitation. Dr. David Jacoby, professor of medicine at Oregon Health and Science University, said he was "very borderline" on his decision and continues to have "serious concerns" about whether the drug will prove safe when used outside the confines of a clinical trial.
"I strongly support warnings in the labeling and a post-marketing study," he said.
The panel voted unanimously that the drug is effective.
COPD is the third-leading cause of death in the United States, according to federal data. The condition is often associated with smoking and can include emphysema, chronic bronchitis, or both.
Investment analysts had been expecting a positive recommendation.
In May, the FDA approved another drug for COPD made by the two companies called Breo. Breo is an inhaled combination of vilanterol and the corticosteroid fluticasone furoate, which reduces inflammation. That drug is expected to generate $1.9 billion by 2018.