EMDAC voted 13 to 3 that the companies had sufficiently established that the low-density lipoprotein cholesterol (LDL-C) lowering benefit of Praluent exceeds its risks to support approval in one or more patient populations.
The recommendation was based on Praluent’s benefit-risk profile, following review of efficacy and safety data from more than 5,000 patients across ten pivotal Phase III double-blind trials ranging from six months to two years.
Data from the ODYSSEY Phase III program show consistent, positive results in reducing LDL-C and the common adverse events that were more frequently reported in patients treated with Praluent than the control groups included injection site reaction and itching.
Sanofi Global R&D president Elias Zerhouni said: "We are pleased with the Committee’s recommendation to approve Praluent.
"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.
"Our Phase III Praluent development program investigated both a 75mg and 150mg dose, providing flexible dosing regimens that can be tailored to individual patient cholesterol level needs."
EMDAC’s recommendation will be considered by the FDA in its review of the Biologics License Application (BLA) for Praluent, which was accepted for priority review by the agency with a target action date of 24 July 2015.
If the companies secure approval from the FDA, Praluent will be the first fully human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in the US.
Currently, the European Medicines Agency (EMA) is reviewing marketing authorization application (MAA) for Praluent in the European Union (EU).
Image: If approved, Praluent injection will be the first fully human monoclonal antibody targeting PCSK9 in the US. Photo: courtesy of Baitong333/ freedigitalphotos.net