Amgen (AMGN) stock was up 2.5% in afternoon trading on the stock market today after the company presented five studies on its new cholesterol drug over the weekend. Results eased safety concerns raised earlier in the month.
At the American College of Cardiology meeting, Amgen shared some of the results from its giant 14-trial phase three program for evolocumab, one of a hot new class of choleserol-fighting drugs called PCSK9 inhibitors. Analysts say the results were in line with phase two studies showing the drug’s effectiveness in lowering LDL (bad) cholesterol in patients for whom the usual treatment of statins is inadequate or intolerable.
Of particular interest in this event, however, was that the studies also didn’t report any significant safety problems. Wall Street zeroed in on evolocumab as the likeliest suspect after the news broke on March 7 that the Food and Drug Administration was aware of adverse neurocognitive events in the PCSK9 class and wanted the companies in the field to watch closely for them. The results seemed to support the theory that the incidents of memory loss in a few patients were due to the statins they were also taking.
“We note that trials where evolocumab was evaluated without use of statins or Zetia (MENDEL-2, GAUSS-2) saw no cognitive AEs (adverse events), while rates were lower in the evolocumab arm of the combo trials,” wrote Nomura analyst Ian Somaiya in a research note Monday. “We believe these data, combined with statin labeling revisions acknowledging reports of cognitive impairment, increase our confidence that evolocumab approval is unlikely to be delayed.”
Analysts said that, as in previous studies, evolocumab’s efficacy was similar to that of its main late-stage competitors, Regeneron/Sanofi’s alirocumab and Pfizer’s bocicizumab. However, the fact that there were no safety issues makes a speedy approval likely, wrote Cowen analyst Eric Schmidt.
“We therefore believe Amgen’s first-mover advantage and noticeably greater ‘buzz’ at the meeting position the company well to capture early share,” Schmidt wrote in a research note Monday. He expects the company to file for approval outside the U.S. this year and domestically a bit later.
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