Cholesterol-lowering Drug Set for FDA Panel
09 Jun 2015 --- French drugmaker Sanofi is set to face the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee today, to hear whether officials will approve its highly-anticipated and experimental drug designed to lower bad cholesterol.
Sanofi’s Praluent is the first in a new class of cholesterol-lowering biotech drugs to come before the FDA, although Amgen’s Repatha will face the panel tomorrow. The drugs are considered the first major advance in lowering bad or LDL cholesterol since the introduction of blockbuster statin drugs in the late 1980s.
Supporters say they hold out hope that these drugs could help millions of Americans with heart disease, but others have warned that if approved this could significantly raise spending on health care, particularly due to the fact the drug has a hefty projected price tag of $10,000 a year for as long as the patient lives.
More than 73m adults in the US have high LDL cholesterol, according to the Centers for Disease Control and Prevention. This equates to nearly one third of the US adult population. Patients who have high cholesterol have double the risk of heart disease.
Studies by Sanofi show that taking Praluent (in addition to a statin) resulted in a drop in cholesterol of 46 to 60%, compared to the 20% drop experienced by patients who solely took the statin.
The FDA will decide today whether to approve the drug based on the evidence which shows its cholesterol lowering qualities, or whether to wait for longer-term studies designed to show whther it actually reduces heart attacks and death in patients. This would mean waiting until 2017.
A similar drug, Repatha, will also be reviewed by the panel tomorrow. This drug is produced by Amgen, and again it lowers LDL in a different way to existing drugs by blocking a substance called PCSK9, which interferes with the liver’s ability to remove cholesterol from the blood.
If approved, those who then decide to take this drug would have to self-inject it every two weeks.
The FDA plans to make its final decision on the drug by July 24.
Meanwhile, Sanofi has also announced plans to resubmit an application for authorisation of its lixisenatide drug for the treatment of type 2 diabetes to the US Food and Drug Administration (FDA) in the third quarter, following a successful study.
The detailed two-year study has shown the heart safety of Sanofi’s injectable type 2 diabetes drug, and it appears to rule out other potential health hazards. The outcome has encouraged the French pharmaceutical company to file for US approval of the medicine.
The drug, which won marketing approval in Europe in 2013 under the brand name Lynxumia, has been subjected to a series of studies, including one called Elixa, which was designed to prove it does not increase serious heart problems in diabetes patients. Sanofi withdrew its original US application in 2013 in order to wait for the results of this study.
The study focused on 6,000 high risk heart patients, most of whom had had a previous heart attack, but the study proved that adding lixisenatide to other standard diabetes treatments did not increase major adverse heart events any more than adding a placebo. After two years 13/4% of patients had experienced one of the major adverse events compared to a nearly identical 13.2% in the placebo group.
The research also showed there was no increase in acute pancreatitis, pancreatic cancer or hospitalizations for heart failure.
“This was the first thing we looked for and it seemed absolutely clean,” explained Rachele Berria, head of Sanofi’s US diabetes medical unit. “And the risk of hypoglycaemia is just not there,” she added.
Lixisenatide is injected once to control blood sugar levels.
