Praluent scores positive trial results in Japan
pharmafile | July 9, 2015 | News story | Research and Development | Japan, PCKS9, Regeneron, Sanofi, heart disease, high cholesterol, praluent
Praluent, the new heart drug from Sanofi and Regeneron, has met its primary endpoint in a Phase III study in Japan, the companies have announced.
A trial of the PCSK9 inhibitor Praluent (alirocumab) injections found it reduced levels of high cholesterol in more than 60% in Japanese patients treated with the drug.
The trial is based on 216 Japanese patients with a high cardiovascular risk and/or with an inherited form of high cholesterol. Patients were initially randomised to receive either Praluent at 75 mg every two weeks or a placebo. Patients in both groups received statins, with or without other lipid-lowering therapies.
Patients were started on the lower dose of 75 mg, with the option to adjust their dose to 150 mg if they had not achieved their low-density lipoprotein cholesterol (LDL-C) at week eight, as defined by the Japan Atherosclerosis Society Guidelines.
After six months patients in the Praluent groupexperienced an average 64% larger reduction from baseline in their bad cholesterol levels, when added to the current standard of care including statins, compared to the standard of care alone.
Some 97% of patients in the Praluent group reached their LDL-C treatment goal, compared to 10% for placebo. The most common adverse events (occurring in at least 5% of patients in the Praluent group) were nasopharyngitis, injection site reactions, and back pain. The results were presented for the first time at the annual scientific meeting of the Japan Atherosclerosis Society in Sendai, Japan.
In June the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommended Praluent should be approved.
Lead investigator Dr Tamio Teramoto, who is director of the Teikyo Academic Research Center, says: “These results demonstrate the significant cholesterol-lowering ability of Praluent among patients with some of the greatest unmet needs in Japan.”
Yasmita Kumar
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