Friday, 21 September, 2018


Regeneron And Sanofi Say Test Shows Praluent Lowers Risk Of Death

Regeneron And Sanofi Say Test Shows Praluent Lowers Risk Of Death Regeneron And Sanofi Say Test Shows Praluent Lowers Risk Of Death
Patty Aguilar | 12 March, 2018, 22:38

Armed with that data, as well as new cost-effectiveness analysis from the US Institute for Clinical and Economic Review (ICER) which provide new estimates of the price range that would be acceptable for the drug - depending on the patient's level of risk.

"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", added Elias Zerhouni, president, Global R&D, Sanofi.

The drug reduced risk of MACE - a composite endpoint defined as heart attack, ischemic stroke, death from coronary heart disease, or unstable angina following hospitalisation - by 15%.

Long-awaited data from the 18,924 patient ODYSSEY OUTCOMES trial, announced at the American College of Cardiology's annual conference in Orlando, showed the study met its primary outcome.

Praluent, or alirocumab, a relatively new cholesterol drug, is effective at lowering heart attack and death risk, according to a study sponsored by manufactuers Sanofi and Regeneron Pharmaceuticals.

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.

People who started the study with LDL cholesterol of 100mg/DL or higher had a 24-percent reduction in the risk of heart attack or stroke and a 29-percent lower risk of death.

Good news for people with very high cholesterol.

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

"We will begin working with payers to ensure that high-risk patients have appropriate access".

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.

As a result, Regeneron and Sanofi will offer payers that agree to reduce onerous access restrictions for high-risk patients an even further reduced net price for the drug.

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.

In terms of safety and tolerability, the only significant difference between the two study groups was minor local site reactions (mild itching, redness or swelling) at the injection site, which occurred in 3.1 percent of those receiving alirocumab and 2.1 percent of those receiving placebo. Approximately 90% of patients were on a high-intensity statin.

For those in the Praluent treatment arm, an estimated 75% of patient time was on the 75 mg 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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