Sanofi and Regeneron post positive alirocumab results
pharmafile | January 9, 2015 | News story | Sales and Marketing | Regeneron, Sanofi, cholesterol, heart, statin, statins
The latest trials of the potentially blockbuster new heart drug alirocumab show it lowers cholesterol in people at moderate and high risk of heart disease.
Alirocumab is an investigational monoclonal antibody targeting a molecule called PCSK9. Previous Phase III studies presented at the American Heart Association annual conference found favourable efficacy and safety results across a range of patient groups.
Sanofi and Regeneron have also announced they have filed the trial results, as part of data from 5,000 patients with high cholesterol, to the EMA for a marketing authorisation application – under the drug name Praluent.
The latest batch of results from the trials ODYSSEY CHOICE I (OCI) and ODYSSEY CHOICE II (OCII) – the first Phase III studies to assess monthly doses of alirocumab – met their primary efficacy endpoints: a significant decrease in ‘bad’ LDL-cholesterol after six months of treatment compared to treatment with a placebo.
OCI evaluated the efficacy and safety of alirocumab 300mg in 803 patients with high cholesterol with a moderate to high risk of heart disease, some of whom were also taking a statin. OCII evaluated the efficacy and safety of alirocumab 150mg in 233 patients with high cholesterol with a high risk of heart disease who didn’t take statins.
“In the new monthly dosing trials, OCI and OCII, the mean per cent reduction in LDL-cholesterol from baseline was consistent with that seen in previous Phase III trials evaluating alirocumab every other week dosing,” Dr Bill Sasiela, cardiovascular and metabolic vice president, at Regeneron says.
“These results continue to validate our clinical development approach, which is designed to investigate various alirocumab doses and intervals to address patients’ lipid-lowering needs.”
The PCSK9-inhibitor class of drugs is aimed at people with high cholesterol who are not able to take statins, or who have taken statins yet are still to hit increasingly low cholesterol treatment targets.
Amgen also have a drug in the pipeline, evolocumab, and having already filed an application with the FDA further ahead of Sanofi/Regeneron and Pfizer’s bococizumab, which is still in development.
Analysts predict impressive sales for alirocumab, but all companies will have to work hard to prove the case for the inevitably high costs of these biologic drugs compared to much cheaper statins.
“The ODYSSEY clinical trial programme has provided key insights and allowed us to investigate alirocumab administered every four weeks in different patient populations, including those who cannot get control of their high LDL-C because of difficulty tolerating statin therapy,” Dr Jay Edelberg, Mhead of the PCSK9 development and launch Unit at Sanofi says.
“Despite current lipid-lowering therapies, many patients at high cardiovascular risk struggle to reach optimal LDL-C levels.”
Lilian Anekwe
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