Sanofi, Regeneron offer price cut for cholesterol drug Praluent

Sanofi, Regeneron offer price cut for cholesterol drug Praluent

"With almost 90 percent of the patients in this trial on high-intensity statins, the data demonstrate that a precision-medicine approach in the field of cardiovascular disease may further advance how we better treat high-risk patients".

On the heels of announcing that the Odyssey Outcomes trial met its primary endpoint, Regeneron Pharmaceuticals, Inc. and Sanofi are ensuring more affordable and timely access to patients who need alirocumab (Pralutent Injection).

The Odyssey Outcomes trial, which met its primary endpoint, was held in almost 19,000 patients who had a recent acute coronary syndrome (ACS) event, such as a heart attack.

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).

Praluent significantly reduced risk of major adverse cardiovascular events (MACE) in patients who had suffered a recent acute coronary syndrome event such as a heart attack.

A first outcomes trial previous year, called Fourier, similarly reported that Repatha, a different PCSK9 inhibitor called evolocumab, reduced the risk of death, heart attack, stroke, hospitalization for angina or revascularization procedures.

Sanofi and Regeneron will be meeting with US health plans to discuss potential net pricing adjustments for those that agree to provide straightforward access for high-risk patients.

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"I've been unconvinced" of the drugs' benefits but now may prescribe them for certain very high risk patients, said Duke University cardiologist Dr. Christopher Granger.

"Not all patients with heart disease are the same", Dr. Elias Zerhouni, president of global research and development for Sanofi said in a company press release. The companies plan to work with cardiology healthcare professionals to define best practices in terms of reducing barriers to access in order to ensure that patients in need have their prescriptions filled quickly and efficiently. They have also agreed to an independent review of the drug's price based on ODYSSEY OUTCOMES. He says Amgen (AMGN -0.9%) would have to cut the price on Repatha (evolocumab) even more to grab market share. But preventing fewer than one heart problem a year at the drug's current price is not cost-effective, he said.

The offer has been made just after the presentation of the large-scale ODYSSEY OUTCOMES at the American College of Cardiology (ACC) meeting in Orlando, which showed that adding PCSK9 inhibitor Praluent (alirocumab) to high-dose statins reduced cardiovascular events and all-cause mortality compared to statins alone.

Patients were randomized equally to be treated either by Praluent injection or a placebo, with the treatment period lasting an average of 2.8 years.

Praluent-treated patients started the trial on 75 mg every 2 weeks, and 2,615 of them switched to 150 mg every 2 weeks because their LDL-C levels remained above 50 mg/dL.

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). It is unclear if benefits would have been more pronounced had more patients received the higher dose. 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.

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