(RxWiki News) If it gets an FDA nod of approval, a new drug could give patients with high cholesterol another treatment option — an option officials said appears to lower cholesterol more than current cholesterol drugs.
Sanofi's Praluent (alirocumab) does appear to lower cholesterol, reports The Associated Press (AP), but US Food and Drug Administration officials said they are unsure whether they should approve it based on only those data or await further study results.
The hesitance, according to Bloomberg Business, may come down to proving whether lowered cholesterol from Praluent actually cuts the risk of heart attack and death. High cholesterol has repeatedly been linked to heart disease in past research. Still, while other cholesterol drugs like statins (brand names Zocor and Lipitor) have been studied specifically for their effects on heart health, Praluent hasn't yet been studied that closely. All that FDA officials said they know is that the Sanofi drug appears to lower cholesterol.
According to the AP, more direct data on Praluent's heart effects isn't expected until 2017.
Praluent is part of a new class of drugs called PCSK9 inhibitors. These drugs work to block a compound that limits the body's ability to get rid of cholesterol. The Sanofi study of Praluent found that, when taken with a lower-intensity statin, this drug appeared to lower cholesterol by 46 to 60 percent. Patients taking just a statin saw a drop of only 20 to 22 percent, the AP reports.
FDA officials noted in a report that the Sanofi data had some limitations, writing that "high-intensity statins ... yield [cholesterol] reductions ranging from -48% to -64%, according to their prescribing information, and some of these doses have proven benefit in cardiovascular outcomes trials. Alirocumab has not been tested ... against such statin doses."
If approved, Praluent would likely be intended for patients who have not been able to control their cholesterol with statins or who cannot take statins due to side effects like muscle pain and weakness, the AP reports.
FDA officials said they plan to further discuss Praluent at a June 9 meeting. The following day, those same officials are set to consider a similar new drug — Amgen's Repatha.