Sanofi/Regeneron cholesterol drug to be reviewed quickly by FDA

The promising new cholesterol drug Praluent, created by Sanofi Pasteur MSD and Regeneration, will undergo a quick assessment by the US Food and Drug Administration (FDA).

A verdict from the governing body is expected as early as July 24th.

The decision from the FDA means that Praluent, also known as alirocumab, could be approved for the treatment of hypercholesterolaemia before Amgen’s competing drug evolocumab, which currently has an FDA Prescription Drug User Fee Act target action date of August 27th.

Both Praluent and evolocumab belong to the closely-watched proprotein convertase subtilisin/kexin type 9 (PCSK9) class of inhibitor, which reduces the liver's ability to remove low-density lipoprotein from the bloodstream.

Amgen has filed a lawsuit in the US against Sanofi and Regeneron, as the firm claims that Praluent infringes three of the patents for evolocumab and is hoping that the case will lead to a total block on sales for its rivals' drug.

The submission for Praluent includes data from more than 5,000 patients, containing information regarding ten Phase III ODYSSEY trials, which will cover more than 23,500 cases when combined with additional ongoing studies.

In addition, European regulators are currently reviewing the drug.