Regeneron And Sanofi Say Test Shows Praluent Lowers Risk Of Death

Regeneron And Sanofi Say Test Shows Praluent Lowers Risk Of Death

"I think that will impress the field and people who have to make (reimbursement) decisions", said Dr. Phillippe Steg, the study's co-chairman who presented the data at the American College of Cardiology meeting in Orlando, Florida.

The drug, Praluent, also led to fewer deaths among high-risk patients, which could be the strongest argument for insurers to finally remove barriers that have severely constrained sales and frustrated physicians trying to get the medicine to patients.

The companies will be providing high-risk patients with a reduced net price for Praluent, in alignment with a new value assessment approach developed by the US Institute for Clinical and Economic Review.

"Not all patients with heart disease are the same".

The trial succeeded on its primary goal - reducing the combined risk of heart attack, stroke, heart disease-related death and chest pain requiring hospitalization - by 15 percent.

"We believe a new paradigm is needed in how all members of the healthcare community collaborate to ensure that patients are able to affordably access the medical treatments they need", said Regeneron chief executive Leonard Schleifer in a statement. "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".

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.

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).

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.

"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. There was no difference in neurocognitive events or new-onset diabetes.

ODYSSEY OUTCOMES assessed the effect of Praluent on the occurrence of MACE in patients who had experienced an ACS between 1-12 months (median 2.6 months) before enrolling in the trial, and who were already on maximally-tolerated statins.

"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".

ICER's latest analysis sets a value-based price range of $4,500-8,000 per year, net of rebates and discounts, for this group, and the companies have said they will offer discounts of up to 69% to health insurers that reduce prescribing obstacles and will be meeting with USA health plans to discuss pricing adjustments.

The companies followed the data with an announcement to cut the price of Praluent (alirocumab) for the high-risk patients who need it the most - a one-two combination aimed at knocking down Amgen and its rival, Repatha (evolocumab). "This is the right thing to do for patients".



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