Sanofi and Regeneron Pharmaceuticals announced Monday that the FDA granted priority review status to a filing seeking approval of the PCSK9 inhibitor Praluent (alirocumab), setting a target action date of July 24. The experimental monoclonal antibody is intended for the treatment of patients with hypercholesterolaemia.
Earlier this month, the companies disclosed that the FDA submission was made during the fourth quarter of 2014, with the filing containing data from more than 5000 patients, including 10 Phase III studies from the ODYSSEY clinical trial programme. Sanofi and Regeneron previously indicated that they would use a priority review voucher purchased from BioMarin Pharmaceuticals for $67.5 million to speed the agency's assessment of Praluent.
A regulatory application for the drug has also been accepted by the European Medicines Agency for review in the EU.
In November last year, the FDA accepted Amgen's marketing application for the experimental PCSK9 inhibitor evolocumab for the treatment of high cholesterol, with the regulator expected to render a decision on the filing by August 27. Amgen has also filed a lawsuit in the US claiming that Praluent infringes several of its patents, with the company seeking an injunction to block the manufacture, use and sale of Sanofi and Regeneron's drug.
Analysts predict that if approved, both Praluent and evolocumab will generate annual sales of more than $2 billion. For related analysis, see ViewPoints: Scrutiny of PCSK9 inhibitor competitive positioning set to increase.
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