FDA Panel Recommends Approval of Second PCSK9 Inhibitor

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FDA Panel Recommends Approval of Second PCSK9 Inhibitor
FDA Panel Recommends Approval of Second PCSK9 Inhibitor

THURSDAY, June 11, 2015 (HealthDay News) -- On Wednesday, U.S. health officials recommended the approval of a second new PCSK9 inhibitor, evolocumab (Repatha).

In an 11 to 4 vote, a U.S. Food and Drug Administration advisory panel endorsed the drug evolocumab (Repatha) for use in patients who are at very high risk for high cholesterol. On Tuesday, the same panel of experts recommended approval of a similar drug known as alirocumab (Praluent). But the advisory panel reiterated concerns that the real benefits of these drugs need to be determined in long-term studies.

How these drugs will be prescribed will depend largely on what prescribing information the FDA writes for these medications, the Associated Press reported. An agency decision on Repatha is due by Aug. 27, while a decision on Praluent is expected by July 24, the news service said.

A recent review of 24 clinical trials -- published online April 28 in the Annals of Internal Medicine -- found that PCSK9 inhibitors lowered people's low-density lipoprotein cholesterol by about 47 percent, on average. More importantly, the drugs seemed to cut the risk of heart attack or death from heart disease, according to the researchers. Experts did urge some caution, however: The trials so far have been short-term, and it's not clear whether the new cholesterol drugs really do extend people's lives, Seth Martin, M.D., a cardiologist at Johns Hopkins University in Baltimore and coauthor of an editorial published with the study, told HealthDay.

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