Amgen has been boosted by the news that regulators in the USA have set an action date for its closely-watched cholesterol drug evolocumab.
The US Food and Drug Administration has accepted for review Amgen's filing for evolocumab, which inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). The latter protein reduces the liver's ability to remove low-density lipoprotein or ‘bad’ cholesterol from the blood and this class of drug is causing much excitement.
The submission for the drug, which was filed at the end of August, is based on data from 6,800 patients, including 4,500 with high cholesterol in ten Phase III trials. Evolocumab ihas been evaluated in patients on statins with or without other lipid-lowerers and those who cannot tolerate statins, as well as patients with heterozygous and homozygous familial hypercholesterolemia.
Decision by August 27
The FDA has set a Prescription Drug User Fee Act target action date of August 27 next year. Amgen will be hoping it can steal a march on Sanofi/Regeneron’s PCSK9 inhibitor alirocumab, which has yet to be filed.
However, the French drugmaker and its partner paid $67.5 million in August to buy a US priority review voucher from BioMarin. This will allow them to fast-track alirocumab as the FDA’s review would take six months not ten.
A submission is likely before the end of the year, meaning that the two PCSK9 inhibitors could get approvals around the same time next summer. To complicate matters, last month Amgen sued its rivals for patent infringement.
Amgen R&D chief Sean Harper said that evolocumab “has the potential to provide significant additional benefit when added to existing LDL cholesterol-lowering medications”.