Amgen's cholesterol drug gets new monthly dose

Amgen’s Repatha (evolocumab) cholesterol drug has received a further boost after the US regulator approved it in a new monthly dose, via an on-body hands-free device with a prefilled cartridge.

The Pushtronex system is an infuser designed to provide 420mg of Repatha in a single dose, giving a treatment option to patients who may not want fortnightly injections.

Repatha is a human monoclonal antibody blocking PCSK9, which inhibits the body’s natural system for eliminating “bad” cholesterol – low density lipoprotein cholesterol (LDL-C) from the blood.

Locked in a battle with Sanofi’s Praluent (alirocumab), launched at the same time, with an almost identical use and in the same class, Amgen is looking for any advantage over its rival.

Amgen has gone as far as taking out a US lawsuit against Sanofi and development partner Regeneron for infringing its patents on Repatha, in an attempt to get Praluent pulled from the market.

Repatha is approved for patients with hereditary forms of high cholesterol - heterozygous familial hypercholesterolemia (HeFH) and a rarer homozygous (HoFH) form of the condition, in addition to those with cardiovascular disease.

Praluent is approved in cardiovascular disease and HeFH but not in HoFH.

This latest development could give Amgen the further leverage over Sanofi as it is the only drug in the class to offer a monthly single-dose delivery option. Praluent is given in fortnightly injections.

The two drugs are almost neck-and-neck in terms of sales following their launches late last year, with Repatha generating $16 million in Q1 and Praluent garnering 12 million euros ($13.3 million) in the same period.

As most small-molecule statins used to treat high cholesterol have gone off patent, this class of drugs is important to the pharma industry as it searches for a new generation of drugs to replace them.