Binds circulating PCSK9 and prevents PCSK9-mediated loss of LDL receptors. Source
Adults with acute coronary syndrome 1–12 months earlier and elevated atherogenic lipoproteins.
Study contextSelected approval record (2015-07-24): FDA first licensed alirocumab as Praluent, before the dedicated cardiovascular-outcome trial reported.
Status sourceStatus & indicationsPrimary cardiovascular composite: HR 0.85 (95% CI 0.78–0.93). Coronary-heart-disease death, nonfatal heart attack, fatal/nonfatal ischemic stroke, or unstable angina requiring hospitalization.
ODYSSEY OUTCOMES · Phase 3 · 75–150 mg subcutaneously every 2 weeks; adjusted to LDL-C target · High-intensity or maximum tolerated statin; alirocumab versus placebo added. · Median randomized follow-up: 2.8 years.
Evidence & limitationsLocal injection-site reactions: 3.8% versus 2.1%; other adverse-event rates were similar.
Safety contextA next milestone is not summarized for this therapy.
Milestone detailsStudy results apply to their own population, dose and analysis. They do not establish a ranking between therapies.
Each result belongs to its own study population, dose and analysis. Open a result for its chart, comparator, safety findings and limitations.
LDL-C: 58 percentage-point reduction vs placebo · 24 weeks
150 mg every 2 weeks
Adults with primary hypercholesterolemia, including HeFH
Pattern-mixture multiple imputation, accounting for adherence.
Label risks include hypersensitivity and injection-site reactions.
Limitations: FDA imputation analysis differs from the original publication. Use this internally consistent label analysis; rounded arm means may not reproduce adjusted differences.
Primary cardiovascular composite: HR 0.85 (95% CI 0.78–0.93). Coronary-heart-disease death, nonfatal heart attack, fatal/nonfatal ischemic stroke, or unstable angina requiring hospitalization.
75–150 mg subcutaneously every 2 weeks; adjusted to LDL-C target
Adults with acute coronary syndrome 1–12 months earlier and elevated atherogenic lipoproteins.
Background treatment & comparator: High-intensity or maximum tolerated statin; alirocumab versus placebo added.
Median randomized follow-up: 2.8 years. Crude proportion with an event during randomized follow-up; median randomized follow-up: 2.8 years.
Local injection-site reactions: 3.8% versus 2.1%; other adverse-event rates were similar.
Limitations: All-cause mortality was nominally lower; hierarchical testing had already stopped at nonsignificant coronary death, so this is not a multiplicity-controlled mortality claim.
Status in this atlas: Selected approval record (2015-07-24): FDA first licensed alirocumab as Praluent, before the dedicated cardiovascular-outcome trial reported. Status source
Binds circulating PCSK9 and prevents PCSK9-mediated loss of LDL receptors.
Mechanism sourceMechanism & side effects: PCSK9 antibodies
Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.
Human IgG1 antibody with two heavy chains and two light chains connected by disulfide bonds.
Shown: Recombinant antibody protein.
Protein architecture is described from the label. No exact whole-antibody atomic structure has been verified for this bundle; a generic antibody icon must not be labeled as the measured drug structure.
DailyMed Praluent label, sections 11 and 12.1Alirocumab · compound history across indications
Selected sourced milestones, not a complete development history. Dates distinguish study starts, publications, announcements and approvals; the first listed date is not necessarily when development began.
Three phase 1 studies of REGN727/SAR236553, later named alirocumab, were published in NEJM. They established early human evidence that blocking PCSK9 could lower LDL-C.
Effect of a Monoclonal Antibody to PCSK9 on LDL Cholesterol — NEJM (2012)The 78-week trial in 2,341 high-risk participants reported LDL-C efficacy and longer-term safety on background statins. It supplies the lipid-response and time-course evidence plotted here; its exploratory cardiovascular analysis was not a substitute for ODYSSEY OUTCOMES.
Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events — NEJM (2015)FDA first licensed alirocumab as Praluent, before the dedicated cardiovascular-outcome trial reported.
FDA Purple Book — Praluent original approval dateAmong 18,924 people with a recent acute coronary syndrome despite intensive or maximally tolerated statins, alirocumab reduced the primary ischemic cardiovascular composite. This is the cardiovascular-outcome trial plotted here.
Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome — NEJM (2018)Selected sources checked Sep 14, 2026. This is not an exhaustive history.