Regeneron/Sanofi in pole position for PCSK inhibitor launch

Sanofi and Regeneron could have approval for their new cholesterol-lowering drug alirocumab in the US before the end of July, giving it a real chance of beating rival Amgen to market.

The Food and Drug Administration (FDA) has set an action date of 24 July for delivering a verdict on alirocumab – which has been given the proposed name Praluent in the US – more than a month before the 27 August target for its review of Amgen’s evolocumab.

The two drugs are leading the field in a new drug class known as the proprotein convertase subtilisin/kexin type 9 or PCSK9 inhibitors, which are expected to become widely used thanks to strong cholesterol-lowering activity as well as their efficacy in patients resistant to, or unable to tolerate, treatment with statins.

The drugs work by boosting the recycling of low density lipoprotein (LDL) cholsterol receptors, allowing them to move more cholesterol out of the circulation.

Both alirocumab and evolocumab are given by injection either once every two weeks or once per month, and have been shown in trials to be more effective than Merck & Co’s Zetia (zetimibe) in patients who cannot tolerate statins, a group which represents up to 20 per cent of all patients with high cholesterol, according to some estimates.

At stake is first-mover advantage in a market predicted to be worth billions of dollars a year, with analysts predicting sales of between $2 billion and $6 billion at peak for the leading drugs in the class.

Sanofi and Regeneron have been able to close the gap on Amgen – which was first to file in the US – thanks to their $67.5 million acquisition last year of an FDA priority review voucher awarded by the FDA to BioMarin Pharmaceutical. BioMarin got the voucher in return for carrying out trials of a new drug in paediatric patients.

The intense competition between the companies in the PCSK9 race has also resulted in legal disputes, with Amgen filing a patent infringement lawsuit against Sanofi and Regeneron last year.

Other PCSK9 inhibitors in the pipeline include Pfizer’s bococizumab, Roche’s and Genentech’s RG7652 and Lilly’s LY3015014, but these remain in clinical testing and Regeneron/Sanofi and Amgen are some way ahead of the trailing pack.

Pfizer is also working on a small-molecule, oral PCSK9 inhibitor that could enter trials this year, as well as a vaccine that could provide long-term cholesterol-lowering from a single shot, potentially given just once a year.

Alirocumab was also submitted for approval in Europe earlier this month, almost four months after Amgen filed evolocumab with the European Medicines Agency (EMA).

Image courtesy of Shutterstock/Alex Mitt


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