Sanofi and Regeneron to expand U.S. access to Praluent

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Sanofi and Regeneron have pledged to make Praluent more accessible to patients as data show that the drug significantly cut the risk of cardiovascular events in high-risk patients.

Regeneron Pharmaceuticals and partner Sanofi report new data this morning from a large, highly-anticipated trial suggesting that their drug alirocumab (Praluent) may reduce the risk of death for people with high cholesterol who have recently suffered heart attacks or strokes and are at risk of having another one or dying.

Regeneron and Sanofi's move to adopt ICER's recommended price range reflects the growing scrutiny of drug costs, and calls for pharmaceutical companies to price their products according to their value to patients, rather than what the market will bear, ICER President Steven D. Pearson said in an interview.

Additionally, alirocumab was associated with a lower risk all-cause mortality (HR=0.85; CI: 0.73-0.98, nominal p=0.026), and there were also fewer CHD deaths (HR=0.92; CI: 0.76-1.11, p=0.38). The MACE composite endpoint includes patients who experienced a heart attack, ischemic stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalization. At the American College of Cardiology meeting, where the data was presented, 62% of the doctors surveyed stated they would change their prescribing habits because of the data. Patients with baseline low-density lipoprotein-cholesterol (LDL-C) at or above 100 mg/dL experienced a more pronounced effect from alirocumab, reducing their risk of MACE by 24% (HR, 0.76; CI, 0.65-0.87). The high-risk group is the estimated 1.3 million people in the USA and Europe who have had heart attacks or strokes and still can't get their LDL-C levels below 100 mg/dL of blood despite treatment with statins. In a post-hoc analysis of this group, alirocumab was associated with a lower risk of death from any cause by 29% (HR, 0.71; CI, 0.56-0.90). The analyses presented included the results from 730 patients (8%) in the Praluent group who continued to be assessed in the Praluent arm despite stopping therapy with the drug, as specified in the protocol for patients with persistent LDL-C readings below 15 mg/dL.

Alongside the data the companies announced plans to boost the affordability and accessibility of Praluent for patients most in need, by offering a reduced net price to United States payers that agree to reduce "burdensome access barriers" for high-risk patients.

Heart disease
GETTYAlirocumab reduces the risk of heart attack or stroke by 24 per cent

There were no new safety signals in the trial. Regeneron will now focus its commercial efforts on those patients, and plans to reach out to payers with a deal: provide "straightforward access for high-risk patients", and it will lower the price of alirocumab, according to a press release.

Odyssey followed patients on average for 3.3 years and the risk reduction versus placebo was increasing over time. "In this trial, such patients who received Praluent on top of maximally-tolerated statins had important reductions in their risk", commented George Yancopoulos, president and chief scientific officer at Regeneron. Approximately 90% of patients were on a high-intensity statin. It's important to note that a comparison between the two trials isn't apples to apples due to differences in design and patient base.

Alirocumab inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells, which lowers LDL-C levels in the blood.

However, the drug had been approved in the U.S. as an adjunct to diet and maximally-tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who need further lowering of LDL-C.

Regeneron and Sanofi's offer of a steep price cut reflects the intensifying pricing pressures that some drugmakers face.