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.
Harper is an employee of Amgen.