Amgen has filed for approval of its PCSK9 inhibitor evolocumab in the US, grabbing a lead in the race to bring the first in a new class of cholesterol therapies to market.
The company’s head of R&D, Sean Harper, said the FDA filing is “the first of several submissions to regulatory authorities around the world for our lipid-lowering programme”.
Amgen is competing with Pfizer and Sanofi/Regeneron in the race to bring a PCSK9 inhibitor to market for hyperlipidaemia and being first to market could help offset the company’s relative lack of experience in the cardiovascular category versus its rivals.
Pfizer’s bococizumab (RN316) and Sanofi/Regeneron’s alirocumab (REGN727 ) have both reported positive results in phase III trials and the latter is expected to be filed for approval before the end of the year.
Giving an indication of the importance attached to reaching the market quickly, Sanofi and Regeneron recently paid $67.5m to purchase an FDA priority review voucher awarded to BioMarin Pharmaceutical by the FDA.
All three PCSK9-targeting antibodies are expected to fulfil a medical unmet need by reducing low-density lipoprotein-cholesterol (LDL-c) in patients who cannot tolerate statins, and a recent market research report by GlobalData suggests they will be the first biologics to enter the mainstream of chronic acute coronary syndromes (ACS) treatment.
“We forecast that they will account for around 40% of ACS sales by 2023, with a global value that slightly exceeds $17.5bn” said GlobalData’s Eric Dimise, who predicted the overall ACS market will triple in size to more than $43bn in the same timeframe.
Amgen’s marketing application for evolocumab in the US is based on the results of 10 phase II studies involving 4,500 patients, either alongside statins in patients unable to meet LDL-c targets or in those who are statin-intolerant.
The programme also included studies in patients with rare, genetic disorders that cause massively increased levels of LDL-c and raise their susceptibility to cardiovascular disease.
In tandem with the filing announcement, Amgen also released results of a phase III trial of evolocumab alongside atrovastatin in Japanese patients with high cardiovascular risk and high cholesterol. The YUKAWA-2 trial met its primary objective of achieving a significant, clinically-relevant reduction in LDL-c within 12 weeks of starting therapy.
“We look forward to working closely with regulatory authorities to bring this new treatment option to patients with high cholesterol,” said Harper.