Anti-cholesterol drug Praluent cuts death risk

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

A first outcomes trial past 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.

Regeneron Pharmaceuticals and partner Sanofi report new data this morning from a large, highly-anticipated trial suggesting that their drug alirocumab (Praluent) may reduce the risk of death for people with high cholesterol who have recently suffered heart attacks or strokes and are at risk of having another one or dying. This is for the first time when a cholesterol drug works effectively to reduce the death rate since statins.

Sanofi and Regeneron have pledged to make Praluent more accessible to patients as data show that the drug significantly cut the risk of cardiovascular events in high-risk patients. The new drugs clearly help people at high risk and are not aimed at people at low risk, such as those who have high cholesterol but have never had a heart attack, he said.

Alongside the data the companies announced plans to boost the affordability and accessibility of Praluent for patients most in need, by offering a reduced net price to United States payers that agree to reduce "burdensome access barriers" for high-risk patients. 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.

It is aimed at patients with high bad cholesterol levels at risk of a fatal heart attack or stroke.

"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.

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Results from the trial were presented during a late-breaker session at the American College of Cardiology's (ACC) 67 Annual Scientific Session in Orlando on Saturday.

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). If the drugs were used more broadly to treat all patients included in the trial, the cost-effective price would be in a range of $2,300 to $3,400 annually, ICER said.

"Sanofi and Regeneron have launched a new initiative that will expand access to their drug Praluent in the United States".

Dr Olivier Brandicourt, chief executive officer of Sanofi, said: "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". Insurers often balk at their high list prices, some $14,000 apiece per patient, per year.

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.

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