Drug makers Sanofi and Regeneron have filed an application with the European Medicines Agency (EMA) seeking approval for their new drug alirocumab for lowering ‘bad’ cholesterol levels.
The new cholesterol-lowering drug, for which the two the pharmaceutical groups have proposed to market under the name Praluent, is also under awaiting green signal from the US Food and Drug Administration (FDA) since the fourth quarter of last year.
Alirocumab belongs to the category of an emerging class of potent injectable drugs that helps in blocking a naturally occurring protein known as PCSK9.
PCSK9 prevents the liver from expelling ‘bad’ or LDL cholesterol from the blood. The new class of drugs that lower bad cholesterol production is called PCSK9 inhibitors, which are mainly used by those people who cannot take the standard cholesterol-lowering treatment called statins.
The marketing application of Sanofi and Regeneron in Europe for their new PCSK9 inhibitor ‘alirocumab’ included the data from over 5,000 patients of LDL cholesterol and ten clinical trials, according to the statement by the companies.
Both Sanofi and Regeneron have high expectations from the experimental drug as they are looking forward to claim their strong hold in the PCSK9 inhibitor market against rivals like Amgen and Pfizer Inc, who are also bringing their drugs in this sector.
According to the health experts and the market analysts, the biotech drugs are emerging as a large market of tomorrow. Moreover, the biotech drugs could constitute a multi-billion market if these medications are successful in lowering the risks of heart attacks and deaths just like statins do.