Washington: A US advisory panel urged regulators Tuesday to approve a new cholesterol drug that promises to reduce death from cardiovascular disease.
The panel voted 13 to three in favor, saying that makers Regeneron and Sanofi had shown that the benefits of Praluent (alirocumab) lowering bad cholesterol (LDL-C) outweigh its risks.
The FDA is not required to follow the advice of the panel, but it often does.
“We are pleased with the committee`s recommendation to approve Praluent,” said Elias Zerhouni, Sanofi`s global research and development president.
“Our clinical trial program focused on patients with high unmet need in which Praluent delivered significant reductions in LDL-C on top of statins and other lipid-lowering therapies.”
The drug, which is injected, works differently from statins.
If approved, Praluent would be the first fully human monoclonal antibody targeting the PCSK9 enzyme.