Regeneron's anti-cholesterol drug Praluent reduces death risk in trial


Regeneron and Amgen have been hoping to make PCSK9 blockers available to more and more of the millions of patients who can't reduce their unsafe cholesterol levels with statins, or can't tolerate them because of side effects.

"This study confirms that PCSK9 inhibitors can reduce the risk of a further heart attack or stroke for people with coronary heart disease". 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.

While fewer heart-related deaths with Praluent did not reach statistical significance, there was a nominally significant reduction in all-cause deaths - 334 versus 392 for placebo, researchers reported. "It has shown that these drugs can reduce the risk of death in such patients, when used alongside statins".

Praluent (alirocumab), an anti-cholesterol drug being developed by Regeneron Pharmaceuticals and Sanofi, has succeeded in the Odyssey Outcomes trial by decreasing the risk of death and heart attack in high-risk patients. Results on the drug, Praluent, were announced Saturday at an American College of Cardiology conference in Florida.

"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.

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.

Doctors focus on lowering LDL, or bad cholesterol, to prevent heart problems.

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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.

Patients receiving Praluent also experienced a statistically valid reduction in the overall risk of death (hazard ratio = 0.85) versus control.

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".

"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 medical treatments they need". Insurers often balk at their high list prices, some $14,000 apiece per patient, per year.

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.

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