FDA’s Advisory committee approves cholesterol-lowering drug Praluent Tuesday

An advisory committee of the US Food and Drug Administration (FDA) has approved a new type of cholesterol-lowering drug Praluent Tuesday.

The drug made by Sanofi SA and Regeneron Pharmaceuticals just got recommended 13 to 3 for approval by a panel. Praluent is a new class of LDL-lowering drugs that inhibits a protein known as PCSK9.

Although the drug has been approved, many panelists agree that the drug should be given to patients with a genetic disorder called familial hypercholesterolemia, or FH, who have very high cholesterol levels and a heightened risk of heart attacks and strokes at a young age.

The opinion of the panelists differed for larger groups of patients. They said they initially want to use of the product limited.

Its use has been limited for to patients who have a genetic predisposition to high cholesterol and the ones who are at high risk of cardiovascular disease and on maximum doses of statin therapy.

The panelists were nervous about offering the drug to patients who were not taking statins, or who said that they could not tolerate statins due to side effects like muscle aches.

Only seven of the panelists were okay to approve the drug or people who can't tolerate statins, and several said they want those patients on maximally tolerated statins. This indicates that if FDA follows the panel's advice, it might approve the drug only for use with a statin.

The panelists want to witness the outcomes of a large ongoing trial, which is accessing whether the drug's LDL-lowering effect translates into reduced cardiovascular risk before it is recommended.