Amid Amgen's pricing war with Sanofi and Regeneron's Praluent, PCSK9 cholesterol fighter Repatha has been looking for a leg up in a wide-ranging clinical program involving dozens of trials. Now, in rarely studied HIV patients, Repatha has posted positive data in lowering cholesterol levels.
Repatha cut LDL-C levels from baseline by 56.9% compared with placebo in HIV patients with abnormally high cholesterol and at elevated risk of cardiovascular disease, according to 24-week data from a phase 3b study released Saturday at the American College of Cardiology scientific sessions.
Repatha also nailed its secondary endpoints in the Beijerinck study, with 71.9% of patients hitting 50% reductions in baseline LDL-C and 65.4% of patients hitting LDL-C levels lower than a predetermined measurement compared with placebo, Amgen said in a release.
The Beijerinck study is part of Amgen's global Proficio program using clinical and real-world evidence to evaluate its lipid-lowering therapies across a broad range of populations, the drugmaker said. So far, Proficio has enrolled 35 clinical trials with more than 41,000 patients and more than 80 real-world studies.
According to Amgen, around 38 million individuals live with HIV worldwide and are at higher risk of cardiovascular disease and dangerously high cholesterol levels.
The Beijerinck data will help build Repatha's case with physicians as it engages in a long-running pricing war with PCSK9 rival Praluent.
Both PCSK9 meds have significantly undershot Street estimates in sales in recent years as they continue to match each other in dropping prices. In January, Amgen opted to sell Repatha at an exclusive $5,850 after Sanofi and Regeneron set that price for Praluent earlier in the year.
As those two fight it out, Novartis has looked to enter the market with inclisiran, a centerpiece of the drugmaker's $9.7 billion acquisition of The Medicines Company last year.
Saturday, a pooled analysis of phase 3 data showed inclisiran cut LDL levels by 51% in patients after nearly a year and a half of treatment. Inclisiran posted durable reductions in LDL cholesterol when used with other lipid-lowering therapies over 17 months. In addition, a preliminary safety analysis noted fewer major cardiac side effects and nonfatal heart attacks compared with placebo, according to Novartis, while overall safety was similar.
Of course, the PCSK9s could face an existential challenge with meds like Esperion's Nexletol and Nexlizet going to market at rock-bottom prices aimed at the pricey older drugs.
In February, Esperion said it would launch both drugs, approved to lower LDL-C in patients with abnormally high cholesterol, at a daily wholesale acquisition cost of $10––far below both Praluent and Repatha's prices.
In January, Esperion Chief Commercial Officer Mark Glickman went directly after Praluent in his attack on the PCSK9 class.
"The biggest mistake that pharma companies made over the last several years is they asked managed care what would be a good price … and then ignored them,” Glickman said at the annual J.P. Morgan Healthcare Conference in January. “I promise you, nobody told Sanofi and Regeneron that $14,000 was a good price for a PCSK9.”