Medication Monitor

Generic Name (Trade Name—Company)
May 1, 2019


(Praluent—Regeneron Pharmaceuticals, Sanofi)
FDA approves expanded indication for cholesterol drug alirocumab

Regeneron and Sanofi announced FDA approval of alirocumab to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease.

Approval for the expanded indication was based on data from the ODYSSEY OUTCOMES trial, which assessed the effect of adding alirocumab to maximally tolerated statins on CV outcomes in 18,924 patients who had an acute coronary syndrome within a year of enrolling in the trial. 

FDA also approved alirocumab as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce LDL-C.

Alirocumab was the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor approved by FDA and is the only PCSK9 inhibitor available in two doses with two levels of efficacy as a single 1-mL injection (75 mg and 150 mg) once every 2 weeks. It can also be administered as 300 mg once every 4 weeks (monthly), enabling physicians to tailor treatment based on an individual patient's LDL-C-lowering needs. 

Alirocumab can cause serious adverse effects, including allergic reactions that can be severe and require treatment in a hospital, such as a severe rash, redness, severe itching, a swollen face, or trouble breathing.

The most common adverse effects are redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms.