FDA approves new once-monthly dosing for Praluent

The US Food and Drug Administration has approved the new supplemental Biologics License Application (sBLA) for a once-monthly (every four weeks), 300mg dose of Praluent (alirocumab) Injection for the treatment of adults with high low-density lipoprotein (LDL) cholesterol, according to the drug’s marketers, Sanofi (Euronext: SAN) and Regeneron Pharmaceuticals (Nasdaq: REGN).

"The FDA approval of once-monthly Praluent is encouraging news for patients with clinical ASCVD or HeFH because it enables physicians to further tailor their treatment to lower LDL cholesterol," said Robert Pordy, vice president of cardiovascular and metabolism therapeutics, Regeneron, which markets the drug in the USA. "Selecting the most appropriate therapy based on individual patient preference is an important consideration for healthcare professionals as high cholesterol treatment often requires long-term management," Dr Pordy added.

"Many patients in the US continue to struggle with high levels of bad cholesterol, or LDL cholesterol, despite diet, exercise and other lipid-lowering therapies, so new dosing options are welcome additions to the treatment landscape," said Corinne Hanotin, global project head, cardiovascular clinical development, Sanofi, adding: "Praluent is now the only PCSK9 inhibitor to offer two dosage strengths with two levels of efficacy, as well as a monthly dosing option."