The Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration (FDA) voted 13-3 on Tuesday to recommend approval of the new drug Praluent Injection, which lowers bad cholesterol (which is linked to heart disease).
"Sanofi and Regeneron [Pharmaceuticals] had sufficiently established that the low-density lipoprotein cholesterol (LDL-C, or bad cholesterol) lowering benefit of Praluent exceeds its risks," said the drug's producer on Wednesday, in a press release on the company's website.
Praluent, generically named alirocumab, is intended for patients who cannot control LDL-C levels using statin drugs, like Lipitor, or those who cannot tolerate such drugs.
"Our clinical trial program focused on patients with high unmet need in which Praluent delivered significant reductions in LDL-C on top of statins and other lipid-lowering therapies," said Sanofi's president of global research and development, Dr. Elias Zerhouni.
The trial used a 75 milligram and a 150 milligram dose to suit individual patient's cholesterol lowering needs, said Zerhouni.
Studies on Praluent, published in March in the New England Journal of Medicine, showed it can cut LDL levels by more than 60 percent.
More than 5,000 patients were involved in the trials, with the medication lasting from six months to two years. The only side effect was itching at the site of the injection, the drug's maker said.
Praluent belongs to a class of medicine called PCSK9-inhibitors, which block a protein (PCSK9) that interferes with the liver's ability to clear LDL-C from the bloodstream.
Some of the advisers, however, expressed concern over insufficient proof that PCSK9 drugs reduce heart-related deaths unlike statins, which have been used by millions of people for more than 20 years.
"I don't believe we have enough data today," said Dr. William R. Hiatt, a cardiologist at the University of Colorado School of Medicine, according to the Wall Street Journal.
The use of Praluent should be limited to patients with the hereditary condition called familial hypercholesterolemia, suggested Brendan M. Everett, director of the cardiology inpatient service at Brigham and Women's Hospital in Boston. The condition, characterized as having very high levels of LDL, begins at birth and can cause heart attacks at an early age, according to the National Library of Medicine.
"I don't want to deprive [patients] of this drug for another two years," said Nancy Geller, a panel member and chief of the Biostatistics Research Branch at the National Heart, Lung and Blood Institute, according to Bloomberg.
Sanofi and Regeneron is doing studies to link the drug to the lowering of the risk of death from heart disease. The studies are scheduled to be completed in 2017.
