Amgen reports positive 52-week data for PCSK9 inhibitor evolocumab

Amgen announced study results showing that monthly treatment with its experimental drug evolocumab led to mean reductions in LDL cholesterol levels of 52 percent after one year with no major increase in serious adverse events compared with standard of care in patients with high cholesterol. The company noted that the data, which were presented at the American Heart Association annual meeting and published in the journal Circulation, are the first from a 52-week study of a PCSK9 inhibitor.

The OSLER extension study included 1104 patients who completed any of four previous Phase II trials of evolocumab. Patients were randomised to receive evolocumab in combination with standard of care or standard of care alone for one year. In addition to the reductions in LDL-C, results showed that Amgen's drug also cut triglycerides levels by about 9 percent, while HDL cholesterol levels increased by around the same percentage.

The company noted that adverse events occurred in 81.4 percent of patients who received evolocumab, versus 73.1 percent who were given standard of care alone. Meanwhile, serious adverse events occurred in 7.1 percent of patients treated with evolocumab and 6.3 percent in the standard-treatment group. Lead researcher Michael Koren suggested that the serious adverse events were not felt to be related to evolocumab. "This gives us a much greater comfort level about possible safety signals," Koren noted.

Sean E. Harper, executive vice president of R&D at Amgen, called the findings "encouraging" and suggested that "evolocumab may be a promising option to treat hyperlipidaemia in a range of at-risk patients." He added that "we look forward to Phase III results from our PROFICIO clinical programme evaluating the safety and efficacy of two distinctive dosing options of evolocumab in a range of at-risk patient populations."

Recent guidelines issued by the American Heart Association and the American College of Cardiology recommending moving away from specific target levels for LDL-C in favour of risk reduction have raised concerns that the uptake of PCSK9 inhibitors may be affected. However, the FDA indicated that such therapies, which are also being developed by Pfizer and a partnership between Sanofi and Regeneron Pharmaceuticals, will only have to meet the agency's existing standards for approval, including whether they cut LDL-C and reduce blood pressure or inflammation.

For related analysis, see Physician Views Poll Results – Implementation of new cholesterol guidelines likely to see moderate increase in statin prescription rate at best, alongside more caution towards PCSK9 inhibitors and ViewPoints: New treatment guidelines reshape the cardiovascular market opportunity; provide another challenge for the much touted PCSK9 inhibitor class.

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