FDA NewsPerspective

FDA approves monthly injection for evolocumab

Amgen announced that the FDA approved a new single-dose monthly injection of its PCSK9 inhibitor evolocumab.

The product is indicated as an adjunct therapy for adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic CVD, and for patients aged 13 and over being treated for homozygous familial hypercholesterolemia, according to a company press release.

The monthly injection (Repatha Pushtronex system, Amgen) consists of an on-body infusor with a prefilled cartridge of evolocumab (Repatha, Amgen) 420 mg. The single-use device, based on the SmartDose technology platform and developed in collaboration with West Pharmaceutical Services, offers patients a hands-free administration that allows the continuation of moderate physical activity like walking, reaching and bending during administration, according to the release.

Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. “The FDA approval of the Pushtronex system offers another delivery option to patients who need the additional LDL lowering that Repatha can provide.”

Evolocumab’s impact on CV morbidity and mortality is still being researched. Data from the GLAGOV trial on its effect on coronary atherosclerosis is expected later this year, and results of the FOURIER outcomes trial of evolocumab in combination with statin therapy will be released in the beginning of 2017, according to the release.

Disclosure: Harper is an employee of Amgen.

Amgen announced that the FDA approved a new single-dose monthly injection of its PCSK9 inhibitor evolocumab.

The product is indicated as an adjunct therapy for adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic CVD, and for patients aged 13 and over being treated for homozygous familial hypercholesterolemia, according to a company press release.

The monthly injection (Repatha Pushtronex system, Amgen) consists of an on-body infusor with a prefilled cartridge of evolocumab (Repatha, Amgen) 420 mg. The single-use device, based on the SmartDose technology platform and developed in collaboration with West Pharmaceutical Services, offers patients a hands-free administration that allows the continuation of moderate physical activity like walking, reaching and bending during administration, according to the release.

Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. “The FDA approval of the Pushtronex system offers another delivery option to patients who need the additional LDL lowering that Repatha can provide.”

Evolocumab’s impact on CV morbidity and mortality is still being researched. Data from the GLAGOV trial on its effect on coronary atherosclerosis is expected later this year, and results of the FOURIER outcomes trial of evolocumab in combination with statin therapy will be released in the beginning of 2017, according to the release.

Disclosure: Harper is an employee of Amgen.

    Perspective
    Michael H. Davidson, MD

    Michael H. Davidson

    The FDA approval of the Pushtronex once-a-month dosing system for evolocumab is a nice addition to our treatment regimen for patients with statin-refractory hypercholesterolemia. Based on surveys of patients in the clinical trials with evolocumab, about half chose once-a-month dosing with the Pushtronex device, and the other half preferred subcutaneous two-week dosing. Patients want dosing options, but to date in my lipid clinic with more than 50 patients on anti-PCSK9 therapies, there is very little resistance to the every-two-week injections. The injections have been surprisingly well-received, with not a single patient stopping the therapy due to the discomfort with the auto-injector pen.

    • Michael H. Davidson, MD
    • Cardiology Today Editorial Board Member
      Clinical Professor of Medicine
      Director, Preventive Cardiology
      University of Chicago Medicine

    Disclosures: Davidson reports consulting and speaking for Amgen and Sanofi/Regeneron.