PRALUENT is a PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor antibody indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-cholesterol (LDL-C).
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Alirocumab (trade name Praluent) is a biopharmaceutical drug approved by the FDA on July 24, 2015 as a second line treatment for high cholesterol for adults whose cholesterol is not controlled by diet and statin treatment. It is a human monoclonal antibody that belongs to a novel class of anti-cholesterol drugs, known as PCSK9 inhibitors, and it was the first such agent to receive FDA approval.
PRALUENTTM (alirocumab) injection, for subcutaneous use Initial U.S. Approval: 2015
Generic Name: Alirocumab
Injection: 75 mg/mL or 150 mg/mL solution in a single-dose pre-filled pen
• Injection: 75 mg/mL or 150 mg/mL solution in a single-dose pre-filled syringe
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For PRALUENT (alirocumab) injection Indications And Usage, Dosage And Administration, Dosage Forms And Strengths and Drug Interactions For More Details
FDA Approves Praluent® (alirocumab) to Prevent Heart Attack, Stroke and Unstable Angina Requiring Hospitalization For More Details
FDA Expands Indication for PCSK9 Alirocumab (Praluent) For More Details