Court orders companies to take cholesterol drug off the market

The makers of the cholesterol-lowering drug Praluent must remove it from the market permanently, a federal judge in Delaware ruled in early January. The move fulfills Amgen’s request for a permanent injunction to prevent the sale, manufacture, and marketing of Praluent, a monoclonal antibody developed by a partnership between Regeneron and Sanofi. Praluent is a competitor to Amgen’s Repatha. Both drugs are inhibitors of the cholesterol regulator proprotein convertase subtilisin/kexin type 9 (PCSK9). Amgen sued Praluent for infringement of two of its patents for monoclonal antibodies and argued that allowing Praluent to remain on the market would cause irreparable harm to its business. Although Amgen was the first to patent its treatment, Praluent was the first inhibitor of PCSK9 to win FDA approval. The judge determined that the damage to Amgen’s business outweighed the public interest in having two drugs on the market. The partnership plans to appeal the injunction before it takes effect in late February and will appeal an earlier decision upholding the validity of Amgen’s patents, the companies say.