FDA approves expanded indication for alirocumab as add-on therapy for homozygous FH
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The FDA has approved the expanded indication for alirocumab injection for adult patients with homozygous familial hypercholesterolemia, or HoFH, as an add-on therapy to other treatments for HoFH.
According to release, alirocumab (Praluent, Sanofi/Regeneron) works by inhibiting PCSK9 protein, which controls the number of LDL receptors that remove LDL from the bloodstream and enables the breakdown of fats and cholesterol.
Alirocumab is given by needle injection under the skin every 2 weeks.
Alirocumab was previously approved to reduce the risk for MI, stroke and unstable angina requiring hospitalization in adults with CVD. In addition, alirocumab is approved to be used alone or in addition to diet or other therapies to treat primary hyperlipidemia, according to the release.
The effectiveness and safety of alirocumab were evaluated in the ODYSSEY HoFH trial that randomly assigned 45patients to 150 mg alirocumab injection every 2 weeks and 24 patients to placebo. The primary endpoint was LDL reduction compared with placebo at 12 weeks.
As Healio previously reported, at 12 weeks, alirocumab reduced LDL by approximately 27% while LDL increased by 8.6% in the placebo group, resulting in an average relative reduction of 35.6%, thus meeting the trial’s primary endpoint (P < .0001). The average absolute reduction in LDL was 62.8 mg/dL in the alirocumab group.
According to the release, common adverse effects of alirocumab include nasopharyngitis, injection site reactions and influenza, and serious allergic reactions have occurred among patients taking alirocumab.
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