Alirocumab

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. The FDA approval was contingent on the completion of further clinical trials to better determine efficacy and safety. 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. The FDA approval was contingent on the completion of further clinical trials to better determine efficacy and safety. 2015 cost is estimated to be $14,300 USD per year, making alirocumab significantly less cost-effective than other lipid-lowering therapies. Alirocumab is used as a second-line treatment to lower LDL cholesterol for adults who have a severe form of hereditary high cholesterol and people with atherosclerosis who require additional lowering of LDL cholesterol when diet and statin treatment have not worked. It is administered by subcutaneous injection. As of July 2015, it is not known whether alirocumab prevents early death from cardiovascular disease or prevents heart attacks; a clinical trial to determine outcomes was ongoing at that time, the results of which were expected in 2017. The New England journal of medicine published on the 7th of November 2018 positive results from a clinical trial with Alirocumab (Praluent). According to the study Praluent significantly reduced major adverse cardiovascular events by 15% and it was associated with a 15% lower risk of death from any cause (hazard ratio 0.85; 95% confidence interval , 0.73 to 0.98) See Side effects that occurred in more than 2% of people treated with alirocumab in clinical trials and that occurred more frequently than with placebo, included nose and throat irritation, injection site reactions and bruising, flu-like symptoms, urinary tract infection, diarrhea, bronchitis and cough, and muscle pain, soreness, and spasms. There are no available data on use of alirocumab in pregnant women to assess risks to the fetus, nor is there data on use in children. Alirocumab works by inhibiting the PCSK9 protein. PCSK9 binds to the low-density lipoprotein receptor (LDLR) (which takes cholesterol out of circulation), and that binding leads to the receptor being degraded, and less LDL cholesterol being removed from circulation. Inhibiting PCSK9 prevents the receptor from being degraded, and promotes removal of LDL cholesterol from circulation. After subcutaneous administration of alirocumab, maximal suppression of free PCSK9 occurs within 4 to 8 hours and has an apparent half-life of 17 to 20 days. Inhibition is dose-dependent. The antibody is distributed through the circulation, and it is eliminated at low concentrations by binding to its target, and at higher concentrations through a proteolytic pathway. Alirocumab is a human monoclonal antibody of the IgG1 isotype. It is made of two disulfide-linked human heavy chains, each disulfide-linked to a human light chain. It has an approximate molecular weight of 146 kDa. It is produced using Chinese hamster ovary cells transfected with recombinant DNA, that are grown in tanks.