FDA approves first once-monthly injection to lower cholesterol

Jul 15, 2016

FDA approved evolocumab (Repatha, Amgen) Pushtronex system, the first monthly single-dose injection of a PCSK9 inhibitor. Repatha was already approved by FDA as the only PCSK9 inhibitor with a monthly dose last August.

FDA approved evolocumab (Repatha, Amgen) Pushtronex system, the first monthly single-dose injection of a PCSK9 inhibitor. Repatha was already approved by FDA as the only PCSK9 inhibitor with a monthly dose last August.

“The FDA approval of the Pushtronex system offers another delivery option to patients who need the additional LDL cholesterol lowering that Repatha can provide,” said Sean E. Harper, MD, executive vice president of research and development at Amgen.

Related: FDA approves major cholesterol drug

Amgen will roll out the drug in early August. While the wholesale acquisition cost of Repatha delivered via Pushtronex is $14,100 annually, the manufacturer expects costs to patients, payers and health systems to be lower “as WAC pricing does not reflect discounts or rebates”.

Repatha is a human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body's natural system for eliminating "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood.

Repatha 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-C. It is also indicatedas an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) over aged 13 years who require additional lowering of LDL-C.

Related: Battle of the cholesterol drugs expected

The new, single-use device was developed in collaboration with West Pharmaceutical Services, based on the SmartDose technology platform, to provide patients with an additional dosing option for Repatha treatment. The device adheres to the body and patients are hands-free during administration. Patients are able to perform moderate physical activities (such as walking, reaching or bending) as the 420 mg of Repatha is delivered subcutaneously.

In clinical trials, the most common adverse reactions were nasopharyngitis, upper respiratory tract infection, influenza, back pain and injection site reactions. In a 52-week trial, adverse reactions led to discontinuation of treatment in 2.2% of Repatha-treated patients and 1% of placebo-treated patients. The most common adverse reaction that led to Repatha treatment discontinuation and occurred at a rate greater than placebo was myalgia.

Read more: FDA panel recommends approving Repatha, Praluent to lower cholesterol

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