Citigroup’s Joel Beatty, while writing about Esperion Therapeutics, argues that the FDA “appears to be raising the regulatory hurdle for cholesterol drugs”.
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Praluent, which is developed by Regeneron Pharmaceuticals Inc. and Sanofi SA, as reported in the Wall Street Journal, will be the first drug of its class, the proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor, in the country.
The drug works by making the liver more efficient at getting rid of LDL, or bad cholesterol.
The FDA approval was based on results in human subjects of the two companies’ phase-three global Odyssey clinical trial program for Praluent.
Specifically, the US Food and Drug Administration has waved through the jab’s use alongside diet and maximum statin therapy in adults with heterozygous familial hypercholesterolaemia, or those with atherosclerotic cardiovascular disease such as heart attacks or strokes, who need additional lowering of LDL cholesterol. For those who don’t know: HeFh is an inherited health disorder that leads to increase in the patient’s LDL cholesterol levels. Dr. Donald A. Smith, an associate professor of medicine and cardiology at Mount Sinai Hospital in New York said, “It focuses on those who’ve truly had clinical disease or those who start out with such high levels of LDL they can’t get anywhere near where they should be and I think those are the most at-risk people”.
The EMA advisors also looked at safety information from over 3,300 patients treated with Praluent and considered the drug’s safety profile to be acceptable, with few patients discontinuing treatment or showing serious adverse events. The drug will also be useful for patients who develop side effects after taking the now available medications.
For years statins like Pfizer’s blockbuster Lipitor have been the gold standard treatment option for patients with high cholesterol levels.
The now available medications for lowering cholesterol are statins, of which there are seven on the market. It is also approved for patients who have had a heart attack or stroke.
Regeneron has already announced that this new drug will be available by early next week. The drug will be marketed in form of a pre-filled pen that patients will have to administer one in every two weeks.
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Regeneron and Sanofi set the newly marketed drug’s wholesale list price in the U.S.at $40 per day for both 75-milligram and 150-milligram doses. Friday was the deadline for the agency to make a decision on whether to approve the drug.
