Monthly PCSK9 Inhibitor Injection Gets FDA Approval

Praluent, a Regeneron and Sanofi adjunct for adults with high low-density lipoprotein (LDL) cholesterol, has received FDA approval for a new once-monthly 300-mg dosing option.

According to a joint release from the two companies, the new 300-mg dose is administered via two 150-mg injections at two different injection sites, with each 1 mL pre-filled pen delivering 150 mg of Praluent in 20 seconds or less. The drug is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL cholesterol.

“Many patients in the US continue to struggle with high levels of bad cholesterol…despite diet, exercise and other lipid-lowering therapies, so new dosing options are welcome additions to the treatment landscape,” said Corinne Hanotin, MD, Global Project Head, Cardiovascular Clinical Development at Sanofi. “Praluent is now the only [proprotein convertase subtilisin/kexin type 9] PCSK9 inhibitor to offer two dosage strengths with two levels of efficacy, as well as a monthly dosing option.”

The once-monthly dose of Praluent was approved by the FDA based on results from the phase 3 Odyssey Choice study, which evaluated the efficacy and safety of Praluent 300-mg every 4 weeks compared to a placebo in patients with hypercholesterolemia who were also taking concomitant statin. The recommended starting dose for Praluent is 75 mg once every two weeks administered subcutaneously, or alternatively, 300 mg once every four weeks for patients who prefer less frequent dosing. Doses can be adjusted to a maximum of 150 mg every 2 weeks for patients requiring greater LDL cholesterol reductions.

“The FDA approval of once-monthly Praluent is encouraging news for patients with clinical ASCVD or HeFH because it enables physicians to further tailor their treatment to lower LDL cholesterol,” said Robert Pordy, MD, Vice President of Cardiovascular and Metabolism Therapeutics at Regeneron. “Selecting the most appropriate therapy based on individual patient preference is an important consideration for healthcare professionals as high cholesterol treatment often requires long-term management.”

Allergic reactions have included hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization. During the Odyssey Choice study, local injection site reactions were reported more frequently in patients who took 300 g of Praluent once a month as compared to patients who took 75 mg of Praluent every two weeks or placebo (16.6%, 9.6% and 7.9% respectively).

Praluent is approved in more than 50 countries globally, including the US, Japan, Canada, Switzerland, Mexico, Brazil and the European Union. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined. The drug is subject to additional monitoring, which will allow quick identification of new safety information.