Single-Dose Evolocumab PCSK9 Inhibitor Seeks FDA Approval

Amgen is seeking FDA approval of a new single-dose option for subcutaneous evolocumab (Repatha).

Evolocumab inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDLC) from the blood.

The drug was recently approved for use in addition to diet and statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease who need extra help lowering their LDLC.

Repatha is available as a single-use 140 mg/mL prefilled SureClick autoinjector or prefilled syringe that patients can self-administer.

Currently, the recommended dose for adults is 140 mg every 2 weeks or 420 mg once a month. For HoFH patients, the recommended dose is 420 mg monthly dose.

Noting that patients in need of lowering their LDLC levels may prefer a single-dose option for receiving Repatha once a month, Amgen has submitted an application to the FDA to allow the 420 mg monthly dose to be administered as a single injection.

Evolocumab is also currently being studied to determine whether its addition to statin therapy can help reduce cardiovascular risk, according to the FDA.

Adverse effects from Repatha may include nasopharyngitis, allergic reactions, upper respiratory tract infection, flu, back pain, and reactions such as redness, pain, or bruising where the injection is given.