As Praluent Q1 sales miss Wall Street expectations, FDA expands drug's label to reflect CV risk reduction
Months after sparring rivals Amgen $AMGN and partners Regeneron $REGN and Sanofi $SNY slashed the prices of their respective PCSK9 inhibitors by 60% to $5,850 in a bid to improve tepid sales of the cholesterol drugs, the latter has secured an additional label that supports their product’s ability to reduce serious cardiovascular events.
Regeneron/Sanofi’s Praluent and Amgen’s Repatha were originally approved in 2015 amidst much fanfare, and were pegged to attain blockbuster status for their ability to dramatically lower levels of LDL cholesterol, but instead faced pushback from insurers for their high sticker prices ($14,000) that led to lower-than-expected adoption, despite later trials that demonstrated the PCSK9 inhibitors also significantly cut the risk of heart attacks and strokes.
Amgen’s Fourier study showed Repatha could significantly reduce the risk of major cardiovascular events, but Regeneron/Sanofi’s Odyssey Outcomes study last year showed that Praluent not only significantly cut the number of cardiovascular incidents, but also demonstrated a clear reduction in deaths from any cause — a goal that eluded Amgen when it unveiled its Fourier data in 2017.
In late 2017, Repatha’s label was updated by the FDA to reflect that the drug could prevent heart attack, stroke and coronary revascularization in adults with established cardiovascular disease. On Friday, Praluent’s label was revised by the agency to show that the drug can prevent heart attack, stroke and unstable angina requiring hospitalization in the same patient population.
On Friday, Sanofi also reported $63 million in first-quarter Praluent sales, “which failed to meet our/consensus expectations of $95 million/$83 million,” Baird’s Brian Skorney wrote in a note, adding that the French drugmaker had noted that US sales were down nearly 27% year-over-year due to the price cut.
“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.
Analysts have predicted that the label expansion should revive Praluent sales.
Amgen is set to report its first quarter results on Tuesday.