FDA grants a new indication for Praluent

The US Food and Drug Administration has approved Praluent (alirocumab) injection for adult patients with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes severely high cholesterol. Praluent is not intended to be used alone but instead added to other treatments for HoFH.

The approval was granted to Regeneron Pharmaceuticals (Nasdaq: REGN), which markets Praluent, a PCSK9 inhibitor, in partnership with French pharma major French partner Sanofi (Euronext: SAN).

Once billed as having blockbuster potential when first launched in 2015, the drug has never been a big seller for the companies. Sanofi registered full-year 2020 revenues from Praluent of 261 million euros ($316 million), while US sale last year came in at $186 million.