Sanofi And Regeneron To Increase Praluent Accessibility For High-Risk Patients

A cost-effectiveness analysis by an independent group incorporated new clinical trial data showing that Praluent reduced the risk of death

Sanofi And Regeneron To Increase Praluent Accessibility For High-Risk Patients

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. That price would be tied to an independent review of Praluent's value based on the new risk reduction data from the multi-year study called Odyssey Outcomes.

The study tested the injected biotech drug versus placebo in almost 19,000 patients who had a recent heart attack or severe chest pain episode and were already on maximum doses of cholesterol-lowering statins, such as Pfizer's Lipitor.

Importantly, however, Praluent also demonstrated a mortality benefit.

The companies will take a precision medicine approach, to address the burden of cardiovascular disease, focusing efforts on high-risk patients most vulnerable for future cardiovascular (CV) events, such as those who have suffered a previous coronary event and are unable to reduce their LDL cholesterol (LDL-C) below 100 mg/dL despite maximally-tolerated statin therapy.

In a post-hoc analysis of this group, Praluent was associated with a lower risk of death from any cause by 29%.

Alirocumab reduced this risk by 24 per cent.

Amgen also tried to have Repatha removed from the market in a patent infringement court case, which Sanofi fought off.

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Both drugs were approved with a few weeks of each other in summer 2015, and have since been made available in patient-friendly monthly jabs, but neither have produced the blockbuster-level sales expected by investors.

In an unusual step aimed at reversing the drug's commercial woes, Sanofi and Regeneron signaled willingness to reduce the net price of Praluent for certain high-risk patients if US payers agree to ease restrictions that have so far limited access to the drug.

Both companies are charging around the same price for their drugs - around $14,000 per year before discounts.

Sanofi and Regeneron said they expect to file a supplementary Biologics License Application to the Food and Drug Administration by the end of the second quarter in hopes of adding the Odyssey data to Praluent's label.

Sanofi also seems to have won over the doctors attending the conference, which will help it in the coming months as the battle with Amgen begins in earnest.

Over the three-year trial, treatment reduced the risk of major adverse cardiovascular events (MACE) by 15% - a similar effect to what was observed in a large study of Amgen Inc.'s rival PCSK9 blocker Repatha (evolucumab) last year. For those in the alirocumab treatment arm, approximately 75% of patient time was on the 75 mg dose. 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. 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. Alirocumab -treated patients started the trial on 75 mg every two weeks, and switched to 150 mg every two weeks if their LDL-C levels remained above 50 mg/dL (n = 2,615).

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