Sanofi and Regeneron’s new cholesterol drug, Praluent, has received a nod of approval from the U.S. Food and Drug Administration (FDA). Approval comes after the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) found that sufficient evidence existed that the benefits of Praluent outweighed the risks of the drug gave a positive recommendation.
The FDA advisory committee based their recommendation on a study of over 5,000 patients in a double-blind, Phase 3 trial used to evaluate the efficacy of the drug compared to the possible risks it may present. Praluent is administered via injection and some patients complained of itching and reactionary conditions around the injection site.
Praluent is the first in a new class of drugs called PCSK9 inhibitors. The drug works by making the liver more efficient at removing LDL, or bad cholesterol, from the body. The cost of the medication will, of course, vary based on a patient’s insurance coverage; however, the wholesale cost is estimated to be around $1,200 per month.
This development of a new cholesterol drug follows the long reign of the blockbuster drug Lipitor, a product of the pharmaceutical giant Pfizer. Lipitor has been the subject of a number of lawsuits for allegedly causing Type II diabetes in women. Lipitor evidence is still being gathered and lawsuits are mounting as cases continue to develop across the nation.
If you or a loved one developed Type II diabetes after taking Lipitor, you may be entitled to financial compensation. Lipitor litigation is ongoing and cases continue to be reviewed. Contact a Lopez McHugh Lipitor lawyer at (877) 737-8525 to discuss your potential case.