安进试验药物erenumab在中期研究显示显著减少了偏头痛天数

http://www.firstwordpharma.com/node/1390256#axzz4BNOXjJh8

安进宣布erenumab到达二期研究主要终点。erenumab为抗降钙素基因相关肽药物（anti-CGRP drug），治疗慢性偏头痛。anti-CGRP drug已被诺华开发，能显著减少偏头痛天数。在erenumab研究中，667位患者被随机分到实验组和对照组，实验组每月减少6.6偏头痛的天数，对比对照组4.2天。安全性两组相当。
有意思的是，JPMorgan分析员说这个结果并不惊喜。

原文请见下文：

Amgen's experimental drug erenumab significantly cuts migraine days in mid-stage study

(Ref: StreetInsider, Financial Times, Xconomy, CNBC, Yahoo!Finance, CTV News, PR Newswire)
June 9th, 2016
By: Joe Barber

Amgen announced that its investigational migraine therapy erenumab achieved the primary endpoint of a Phase II study evaluating the efficacy and safety of the treatment for chronic migraine prevention. The anti-CGRP drug, which is being developed with Novartis, was found to significantly reduce the number of migraine days versus placebo, in line with prior mid-stage study results reported in May last year. Amgen R&D chief Sean Harper remarked "these positive results are exciting because they add to the growing body of evidence supporting erenumab for the prevention of migraine."

In the study, 667 patients were randomised to once-monthly treatment with subcutaneous erenumab, at one of two doses, or placebo for 12 weeks. The primary endpoint was the change in migraine days from baseline to the last four weeks of the treatment period, while secondary endpoints included a reduction of at least 50 percent from baseline in monthly migraine days, the change from baseline in monthly acute migraine-specific medication days and the change from baseline in cumulative monthly headache hours.

Study findings showed that patients administered erunumab experienced a 6.6-day reduction in monthly migraine days versus a 4.2- day reduction in the placebo group. Amgen noted that the safety profile of erenumab was similar across both dose groups, with no adverse event being observed in more than 5 percent of patients. The company said that additional analyses of the study data are ongoing, with results to be submitted for presentation at a future medical meeting as well as for publication.

"Amgen and Novartis look forward to discussing these results with global regulators," commented Amgen spokeswoman Kristen Davis, adding "we believe that together with the Phase III episodic data that we expect in [the second half of 2016], the data could potentially support both chronic and episodic indications being granted, at least by some of the global regulators."

Commenting on the news, JPMorgan analysts stated that the results were not surprising "given the consistency in treatment effect we've seen from all the CGRP inhibitors in development." The analysts further remarked "we continue to view [erenumab] as one of the more important growth drivers for Amgen over the near-to-intermediate term and recognise the commercial potential that chronic and episodic migraine present."

Meanwhile, ISI Evercore analyst Mark Schoenebaum explained that the data for erenumab were "roughly comparable" to results reported for experimental migraine treatments under development by Teva and Alder Biopharmaceuticals. However, the analyst cautioned that Amgen did not provide full results for the primary endpoint or discuss any data for the secondary endpoints.

For related analysis, read Physician Views Poll Results: Has enthusiasm for anti-CGRP mAbs been affected by recent clinical readouts?, as well as KOL Views: Neurologist weighs in on how the race among anti-CGRP mAbs is shaping up.