FDA expands Praluent label to stress CV risk reduction

The FDA has expanded Praluent’s (alirocumab) regulatory approval to reflect the reduced risk of heart attack, stroke and unstable angina evidenced in 2018’s ODYSSEY OUTCOMES trial—a move announced the same day drugmaker Sanofi released its first-quarter earnings, which were lower than expected.

According to the FDA’s approval statement, which was issued April 26, Praluent’s label will now include the CVD risk-reduction benefits proven in the ODYSSEY study. That study, the longest CV outcomes trial of any PCSK9 inhibitor to date, found that adding Praluent to maximally-tolerated statins in 18,923 patients with an acute coronary syndrome reduced the risk of major CV events 15%, the risk of stroke 27%, the risk of non-fatal MI 14% and the risk of death 15%.

The FDA also extended Praluent’s indication to include patients with other types of high LDL-cholesterol. The PCSK9 inhibitor is now federally approved as an adjunct to diet, alone or in combination with other lipid-lowering therapies like statins or ezetimibe, to treat hyperlipidemia in eligible adults.

As is the case with other PCSK9 inhibitors, Praluent’s makers, Sanofi and Regeneron, have faced considerable criticism when it comes to the drug’s cost. Praluent’s annual price tag initially exceeded $14,000, but last spring Sanofi and Regeneron pledged to slash prices by more than half for insurers.

The drugmakers undoubtedly hoped the dramatic price cut—down to $5,850 a year—would improve sales of Praluent, but Sanofi’s first-quarter results, also reported April 26, reflected far lower earnings than the companies had projected. Baird’s Brian Skorney told Endpoints News that Sanofi had expected sales of between $83 million and $95 million in the first quarter; in reality, the company reached just $63 million.

“However, Sanofi continues to expect that Praluent volumes will increase in the coming year, as they have seen greater uptake in the Medicare population since the launch of a low-cost version of the medication,” Skorney said.

Amgen, which manufactures the competing PCSK9 inhibitor Repatha (evolocumab), is slated to report its first-quarter results April 30. Repatha’s label, too, was updated by the FDA in 2017 to reflect that the drug could prevent MI, stroke and coronary revascularization in patients with established heart disease.