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Praluent FDA Approved

Posted in Cardiovascular Pharmacogenomics, Cardiovascular Research, Clinical & Translational, Curation, Molecular Genetics & Pharmaceutical, Pharmacotherapy of Cardiovascular Disease, tagged Cardiovascular disease, LDL cholesterol lowering, statins on October 31, 2015| Leave a Comment »

Praluent FDA Approved

Larry H. Bernstein, MD, FCAP, Curator

LPBI

PRALUENT^® (alirocumab) is now approved for additional LDL-C lowering on top of maximally tolerated statin therapy in patients with HeFH or clinical ASCVD¹

INDICATIONS AND USAGE

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-C.

The effect of PRALUENT on cardiovascular morbidity and mortality has not been determined.

DOSING INFORMATION

The recommended starting dose of PRALUENT is 75 mg administered subcutaneously once every 2 weeks, since the majority of patients achieve sufficient LDL-C reduction with this dosage. If the LDL-C response is inadequate, the dosage may be increased to the maximum dosage of 150 mg administered every 2 weeks.

Measure LDL-C levels within 4 to 8 weeks of initiating or titrating PRALUENT to assess response and adjust the dose, if needed.

PRALUENT is a human monoclonal antibody that binds to PCSK9¹

PRALUENT efficacy was investigated in 5 double-blind, placebo-controlled trials with 3499 patients enrolled: 36% with HeFH and 54% non-FH with clinical ASCVD.

•	All patients were receiving a maximally tolerated dose of statin with or without other lipid-modifying therapies

•	3 studies used an initial dose of 75 mg Q2W as part of an up-titration regimen with criteria-based up-titration to 150 mg Q2W at week 12 for patients who did not achieve their prespecified target LDL-C at week 8

•	2 studies with 150 mg Q2W dose only

Clinical ASCVD is defined in the ACC/AHA guidelines² as acute coronary syndromes or a history of any of the following: myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, transient ischemic attack or stroke, or peripheral arterial disease presumed to be of atherosclerotic origin.

All studies met their primary efficacy endpoint measured at week 24¹

•	All trials were at least 52 weeks in duration with the primary efficacy endpoint measured at week 24 (mean percent change in LDL-C from baseline)

The first and only FDA-approved PCSK9 inhibitor with 2 doses that allows you to adjust the dose based on your patients’ LDL-C lowering needs¹

MyPRALUENT™: Comprehensive support for you and your patients

•	MyPRALUENT is designed to help meet your needs and your patients’ needs

•	Speak with a MyPRALUENT Care Specialist at 1-844-PRALUENT (1-844-772-5836), option 1

IMPORTANT SAFETY INFORMATION

PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to PRALUENT. Reactions have included hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization.

Hypersensitivity reactions (e.g., pruritus, rash, urticaria), including some serious events (e.g., hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization), have been reported with PRALUENT treatment. If signs or symptoms of serious allergic reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve.

The most commonly occurring adverse reactions (≥5% of patients treated with PRALUENT and occurring more frequently than with placebo) are nasopharyngitis, injection site reactions, and influenza.

Local injection site reactions including erythema/redness, itching, swelling, and pain/tenderness were reported more frequently in patients treated with PRALUENT (7.2% versus 5.1% for PRALUENT and placebo, respectively). Few patients discontinued treatment because of these reactions (0.2% versus 0.4% for PRALUENT and placebo, respectively), but patients receiving PRALUENT had a greater number of injection site reactions, had more reports of associated symptoms, and had reactions of longer average duration than patients receiving placebo.

Neurocognitive events were reported in 0.8% of patients treated with PRALUENT and 0.7% of patients treated with placebo. Confusion or memory impairment were reported more frequently by those treated with PRALUENT (0.2% for each) than in those treated with placebo (<0.1% for each).

Liver-related disorders (primarily related to abnormalities in liver enzymes) were reported in 2.5% of patients treated with PRALUENT and 1.8% of patients treated with placebo, leading to treatment discontinuation in 0.4% and 0.2% of patients, respectively. Increases in serum transaminases to greater than 3 times the upper limit of normal occurred in 1.7% of patients treated with PRALUENT and 1.4% of patients treated with placebo.

The most common adverse reactions leading to treatment discontinuation in patients treated with PRALUENT were allergic reactions (0.6% versus 0.2% for PRALUENT and placebo, respectively) and elevated liver enzymes (0.3% versus <0.1%).

PRALUENT is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with PRALUENT.

Please see full Prescribing Information.