US appeals court allows Sanofi, Regeneron to continue selling PCSK9 inhibitor Praluent

Sanofi and Regeneron Pharmaceuticals announced that the US Court of Appeals for the Federal Circuit suspended a permanent injunction on Praluent (alirocumab) pending the companies' appeal. The drugmakers noted that the ruling means that they will continue marketing, selling and manufacturing the PCSK9 inhibitor in the US during the appeal process.

Last month, a US district court upheld a request from Amgen and granted a permanent injunction preventing Sanofi and Regeneron from marketing, selling or manufacturing Praluent in the country. Amgen claimed that Praluent infringed two patents covering its own PCSK9 inhibitor Repatha (evolocumab).

Sanofi and Regeneron are challenging both the injunction ruling and the jury's earlier finding upholding the validity of Amgen's patents. "This decision is important for patients in the US who will continue to have access to Praluent during the appeal process giving them a choice in PCSK9 inhibitor treatments," commented Karen Linehan, general counsel at Sanofi. "It is our longstanding position that Amgen's asserted patent claims are invalid and we look forward to moving forward with the appeal process," Linehan added.

Amgen spokeswoman Kristen Davis said that the company respected the court's decision, but was confident it would prevail against Sanofi and Regeneron's appeal. For related analysis, read ViewPoints: Reasons to believe anti-PCSK9 battle is not headed for a 'Mircera moment'.

Praluent was approved by the FDA in July 2015, making it the first PCSK9 inhibitor to be authorised in the US for use as adjunct to diet and maximally-tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolaemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL cholesterol. Repatha was authorised the following month by the agency.

For related analysis, read also ViewPoints: The Medicines Co. keeps winning from sideline in PCSK9 battle.