In addition to significantly reducing the primary endpoint-a combined rate of heart attack, stroke, hospitalization for unstable angina or death from coronary heart disease-alirocumab was also associated with a 15 percent reduction in death from any cause among the full patient population and a 29 percent reduction in death from any cause among those who started the trial with LDL cholesterol above 100 mg/dL.
The results were presented Saturday at a major cardiology conference.
High-risk patients who were subjected to Praluent injection in combination with maximally-tolerated statins had significantly lesser major adverse cardiovascular events compared to patients treated on only maximally-tolerated statins.
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Both drugs, which were approved in 2015, work by blocking a protein called PCSK9, thereby freeing up the body to clear out LDL in the blood.
Dr. Valentin Fuster, who critiqued the trial at the meeting but was not involved in the study, said the data show that what is considered normal LDL today may be too high. "But is this going to be a huge change?"
"We were really pleased to see the treatment was effective and associated with a reduction in mortality". Each has been a commercial disappointment since winning approval, despite repeatedly demonstrating dramatic effects on cholesterol. They have routinely rejected about 70 percent of prescriptions written, the companies have said.
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To mimic the adjustments a doctor might make when using the drug, those patients randomized to receive alirocumab had their doses adjusted in a blinded fashion (neither patients nor doctors were aware of the adjustments) in efforts to reach LDL cholesterol levels of 25-50 mg/dL. But the discount deal would apply only to patients with dangerously high levels of cholesterol who are at particularly high risk for heart attack or stroke. It's the first time a cholesterol-lowering drug has reduced deaths since statins such as Lipitor and Crestor came out decades ago.
To help ensure more affordable and timely access to patients most in need, Sanofi and Regeneron Pharmaceuticals will offer U.S. payers that agree to reduce burdensome access barriers for high-risk patients a further reduced net price for Praluent (alirocumab) Injection in alignment with a new value assessment for high-risk patients from the U.S. Institute for Clinical and Economic Review (ICER).
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 USA payers that agree to reduce "burdensome access barriers" for high-risk patients. It is unclear if benefits would have been more pronounced had more patients received the higher dose.
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From 300,000 to 400,000 people in the US each year fall in that second category. He says Amgen (AMGN -0.9%) would have to cut the price on Repatha (evolocumab) even more to grab market share. But neither drug is anywhere close to the $3 billion in annual sales Wall Street once forecast. Amgen - which has been locked in litigation with Sanofi and Regeneron over PCSK9 patent rights - reported positive cardiovascular outcomes data for its drug previous year when it published the results of the FOURIER trial. Analysts roundly predicted Praluent to mirror Amgen's results, noting that an effect on mortality could shift the competitive dynamic between the drugs.