FDA Panel Approves Sanofi’s Cholesterol-Lowering Drug amid Reservations

Sanofi and Pharmaceuticals’ new cholesterol-lowering drug, Praluent, finally cleared the watchful eye of the US Food and Drug Administration, on Tuesday.

The panel of experts voted 13-3 to approve Praluent, which precedes the approval of another LDL-lowering drug Repatha by Amgen Inc, due on Wednesday. Though the panel gave a green signal to Praluent, it has few reservations that it spelt out before the FDA. However, the FDA is under no obligation to follow the panel’s recommendations.

Firstly, the panelists were cynical on the cardiovascular benefit of the new class of LDL-lowering drug. Unlike statins, whose effect in lowering incidence of heart diseases is proven, the new drug is yet to prove its mettle. Secondly, they thought the drug might affect cognition and the liver. They also feared that this new drug could increase the risk of diabetes in patients. Lastly, they opined that when this new drug was taken with statins, the combined dose might lower LDL too much, which might require taking patients off statins.

However, Sanofi has hopes of completing the enrollment in an 18,000-patient trial by the end of the year, to gauge if the drug’s LDL-lowering effect translates into reduced cardiovascular risk as well. The results of this large ongoing trial are expected by the end of 2017.

The two drugs in question, Praluent and Repatha, are mainly PCSK9 inhibitors that cut bad or LDL cholesterol. However, they work differently from the existing statins drugs. While statins are pills, the new drugs require the patients to inject themselves every two to four weeks.