Amgen will be breathing a huge sigh of relief after US regulatory advisors recommended approval of its cholesterol-buster Repatha, just a day after backing Sanofi/Regeneron’s rival PCSK9 inhibitor Praluent.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 15-0 in support of a green light for the drug as a treatment for patients with homozygous familial hypercholesterolaemia, and 11-4 in favour of its use in those with the less rare heterozygous familial hypercholesterolaemia form.
Echoing concerns voiced on Praluent (alirocumab), use of Repatha (evolocumab) could initially only be restricted to patients at highest risk, until longer-term cardiovascular outcomes data is available.
The drugs are currently racing to be the first in the new PCSK9 inhibiting class of drugs - which are expected to generate billions of dollars in revenue - to hit the US market. Going on FDA action dates, Praluent could be the first with final decision expected by July 24, while a ruling on Repatha isn’t due until August 27.