Regeneron to Make Alirocumab More Accessible After Data Shows Reduced Risk and Death Rate

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).

In the study, it was observed that alirocumab significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered a recent acute coronary syndrome (ACS) event, like a heart attack. 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. The new price will be in alignment with a value assessment for this population from the Institute for Clinical and Economic Review (ICER).

Results from the trial were presented during a late-breaker session at the American College of Cardiology’s (ACC) 67^th Annual Scientific Session in Orlando on Saturday. The data showed alirocumab’s ability to reduce the overall risk of MACE by 15% (HR=0.85, CI: 0.78-0.93, p=0.0003). The MACE composite endpoint included patients who experienced a heart attack, ischemic stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalization.

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).

"Not all patients with heart disease are the same. Through this trial, we have been able to identify high-risk patients treated with optimal statins who still have an urgent need for additional treatment options," said Elias Zerhouni, M.D., President, Global R&D, Sanofi in a press release. "With nearly 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."

In a pre-specified analysis, the patients with baseline LDL cholesterol (LDL-C) levels 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), and in a post-hoc analysis of the same group, the drug was associated with a lower risk of death from any cause by 29% (HR=0.71, CI: 0.56-0.90).

Alirocumab inhibits the binding of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the LDL receptor and thus heightens the number of available LDL receptors on the surface of liver cells. As a result, LDL-C levels in the blood are reduced. 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.

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

"This trial was consistent with earlier statin trials, showing the greatest benefit in patients with higher cholesterol levels at baseline," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer, Regeneron. "Many patients who have survived a recent heart attack or other coronary event are unable to reach an LDL cholesterol goal of less than 100 mg/dL, and have an urgent need for new therapeutic options because of their increased risk of another event. In this trial, such patients who received Praluent on top of maximally-tolerated statins had important reductions in their risk."

Representatives from the two companies will meet with health plans to examine prospective net pricing adjustments for those that agree to provide straightforward access to high-risk patients.

"Too many patients in urgent need of additional treatment options on top of statins have faced tremendous hurdles to gain access to this important medicine. We are prepared to improve access and affordability, eliminating burdensome barriers for high-risk patients in need," said Olivier Brandicourt, MD, Chief Executive Officer, Sanofi in a statement.

"We will begin working with payers to ensure that high-risk patients have appropriate access. This is the right thing to do for patients."

For more from the ACC 67^th Annual Scientific Session, follow Rare Disease Report on Facebook and Twitter.