FDA advisory committee recommends approval for cholesterol lowering drug alirocumab

The US Food and Drug Administration (FDA) advisory committee decided in favour of the first two candidates in a new class of heart drugs since the cholesterol-lowering statins emerged in the 1980s.

The committee looked at studies involving alirocumab, developed by Sanofi and Regeneron Pharmaceuticals, and similar compound, evolocumab from Amgen. Meanwhile Pfizer had also lined up a drug which would be further behind in the approval process.

The new class called PCSK9 inhibitors, work by pumping out more LDL cholesterol receptors on liver cells; and can pull cholesterol out of the blood like sponges and keep vessels clear of the artery-clogging fats.

Alirocumab received a 13-3 vote at the committee meeting, which had determined that it was safe enough and provided significant enough benefits over existing therapies that it should be approved. Though the FDA usually follows its advisory committee recommendations, it is not bound by the advice.

The recommendation does not come as a surprise given the encouraging data so far on the drugs, but it was somewhat unusual as there was no long-term data yet on how patients taking these drugs fared according to commentators.

The agency would be expected to follow the committee's advice when it decided whether to approve the drugs, alirocumab (Praluent) from Sanofi SA and Regeneron Pharmaceuticals Inc, and evolocumab (Repatha) from Amgen Inc, for patients later this summer.

The drugs represent the most important new class of cholesterol-lowering medications since the approval of the first statin in 1987. The US had seven statins available, including a

The new drugs were a "powerful new way of lowering the bad form of cholesterol, and that has profound implications in dealing with the burden of vascular disease," which could lead to heart attacks and stroke, according to Elliott Antman, president of the American Heart Association, CNN reported.

Although statins were likely to be a mainstay for the management of high levels of bad (LDL) cholesterol and reducing risk of heart attack and stroke, Antman said there were two groups of patients who could strongly benefit from having an alternative to statins.

One was the group that suffered severe side effects to statins, and consequently might stop taking them. The most common side effect was muscle pain and weakness, which is estimated to affect between 10 per cent and 25 per cent of users.

In contrast, clinical trials of alirocumab and evolocumab did not find an increase in muscle pain among study participants taking these drugs for several months compared with those taking a placebo control.

The other group was people whose levels of LDL cholesterol still hovered around the desirable range even after taking statins.