Sanofi, Regeneron to cut price of Praluent

Sanofi, Regeneron to cut price of Praluent

Sanofi, Regeneron to cut price of Praluent

The study also showed that Praluent caused a reduction in all-cause death. The trial was created to maintain patients' LDL-C levels between 25-50 mg/dL, using two different doses of Praluent (75 mg and 150 mg). Importantly, no significant safety signals were seen across the study of nearly 19,000 patients.

The findings described Saturday at the American College of Cardiology conference in Orlando, Florida, were based on an worldwide trial of almost 19,000 people randomly assigned to either alirocumab or a placebo. Get this and other reports immediately when you try Morningstar Premium free for 14 days.

There were no new safety signals in the trial. The findings are welcome news for the drug's manufacturers, as the high list price has proven unpalatable to insurance companies.

The companies will meet with USA healthcare providers to to discuss potential net pricing adjustments for those that agree to provide straightforward access for high-risk patients, while working with healthcare professionals to define best practices.

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In a subgroup analysis of highest-risk patients - those with "bad" LDL cholesterol of 100 or above despite maximum statin therapy - Praluent significantly reduced all-cause death risk by 29 percent and risk of the adverse event composite by 24 percent. "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. The organization recommended a price range of $4,500 to $8,000 for those high-risk patients likely to gain the most benefit from Praluent therapy. All patients were randomized to receive alirocumab (n = 9,462) or a placebo (n = 9,462) and were treated for a median of 2.8 years, with some patients being treated for up to five years.

With an LDL target range of 25-50, rather than taking it as low as possible, three-quarters of patients ended up on a lower dose of Praluent and some were taken off the drug if their LDL remained at 15 or lower.

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.

Sources: Regeneron (study results); March 10, 2018; Regeneron (pricing offer); March 10, 2018; ICER, March 10, 2018.

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