FDA Approves First Single Monthly Injection For Abnormal Cholesterol
US FDA approved the first and the only Amgen’s Repatha® (evolocumab) Pushtronex™ system (on-body infusor with prefilled cartridge) to combat increased levels of low density lipoprotein cholesterol (LDL-C) which could increase the risk of cardiovascular disease if left unchecked.
The device Pushtronex is a hands-free system, designed to administer monthly, single dose of 420 mg of Repatha. Evolocumab, a human monoclonal antibody, helps in the elimination of LDL-C (‘bad’ cholesterol) from the body. It works by blocking the action of protein proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the natural mechanism of the body to remove LDL-C from the blood.
Figure 1. Amgen’s Repatha® (evolocumab) Pushtronex™ system (photo credit: fiercepharma.com).
Repatha binds to the circulating PCSK9 and prevents them from binding to the low-density lipoprotein receptor (LDLR) and therefore prevents the degradation of LDLR and increases their number, so finally they can clear the LDL from the blood leading to reduced LDL-C levels.
Figure 2. Mechanism of action of evolocumab (photo credit: ACCP Cardiology PRN Journal Club).
What sets Repatha apart is that it is the first and only PCSK9 inhibitor to be offered in a single monthly dose delivery option. It is indicated as an adjunct in US for adult patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD).
Figure 3. Deposits of the yellowish patches of cholesterol above the eyelids is common symptom of familial hypercholesterolemia (photo credit: Wikipedia).
It may also be used as an adjunct for patients over the age of 13 with homozygous familial hypercholesterolemia in need of additional lowering of LDL-C.
The device was developed in collaboration with West Pharmaceutical Services, it is based on the SmartDose® technology platform, providing patients with an additional dosing option for Repatha treatment.
The single use device adheres to the body and enables hands free, subcutaneous administration of the drug in the body. Patients can perform moderate physical activities with administration of the drug. It is estimated to be made available to patients in the U.S.A in early August.
“The Pushtronex system exemplifies Amgen’s continued innovation and commitment to patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration. The FDA approval of the Pushtronex system offers another delivery option to patients who need the additional LDL cholesterol lowering that Repatha can provide.”
Featured Image: Low-density lipoprotein (LDL) particles in blood plasma. © animaxx3d (Stock Photo ID: 120173774)