Product/Composition:- | Alirocumab Subcutaneous Injection |
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Strength:- | 75 mg/mL and 150 mg/mL |
Form:- | Subcutaneous Injection |
Reference Brands:- | Praluent(US & EU) |
MOQ | As per the manufacturer batch size |
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Alirocumab is a monoclonal antibody that inhibits PCSK9, increasing LDL receptor availability to enhance LDL cholesterol clearance from the blood. It effectively lowers LDL levels, reducing cardiovascular risk. Benefits include significant LDL reductions, improved heart health, and prevention of atherosclerotic events in high-risk patients.
Alirocumab, marketed as Praluent, is approved in the US by the FDA and in the EU via EMA for lowering LDL cholesterol in patients with familial hypercholesterolemia or cardiovascular risk. Regulatory approval requires a comprehensive dossier including clinical trial data, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical and quality data to ensure safety and efficacy, while the EMA evaluates regional safety and manufacturing compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regulatory adherence supports timely approval, safe use, and global availability of alirocumab subcutaneous injections, contributing to improved cardiovascular health worldwide.