Committee Endorses Praluent for High Cholesterol Patients
The Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 3 last week to recommend approval of Sanofi and Regeneron’s cholesterol-lowering drug Praluent, but said more data is needed to support the drug’s effect on cardiovascular outcomes.
While the vote shows confidence in Praluent (alirocumab) — the drug reduced bad LDL cholesterol by 45 percent at 12 weeks in clinical studies — there was no long-term clinical trial data that could shed light on potential cardiovascular disease issues, said committee chairman Robert Smith.
At the same time, panelists pointed out that if they voted against recommending the drug until such results are available, patients with high cholesterol would be denied the drug for two or more years.
Citing an unmet need, the panel ultimately agreed that Praluent should be approved for patients with a familial history of high cholesterol and those with high cardiovascular risk.
The panel also expressed lingering concerns about the drug’s safety, saying that while the data showed no major safety signals, there was inadequate information on adverse events, including immunogenicity, diabetes and neurocognitive events. An ongoing patient outcomes trial may answer some of these questions, the committee members said.
Praluent is one of two PCSK9 inhibitor drugs being considered by the committee. The other is Amgen’s Repatha (evolocumab). — John Bechtel