12 Jul 2016

Amgen got USFDA Approval For Once-Monthly Cholesterol-lowering Evolocumab (Repatha) Device

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TagsAmgen, case study new drug approval, Evolocumab

The US Food and Drug Administration (FDA) has approved the evolocumab (Repatha, Amgen) Pushtronex system, the first once-monthly delivery option for a proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor.

Evolocumab is currently given as a subcutaneous injection via a 140-mg prefilled autoinjector or syringe that patients can self-administer every 2 weeks or 420 mg once a month. The Pushtronex system is a hands-free infusor that adheres to the body and provides 420 mg of evolocumab in a single dose.

Evolocumab is indicated as an adjunct to diet and maximally-tolerated statin therapy to lower LDL cholesterol in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, and as an adjunct to diet and other LDL-lowering therapies for patients with homozygous familial hypercholesterolemia aged at least 13 years.

The Pushtronex system will be available to US patients early August 2016, according to Amgen.

The new device was developed in collaboration with West Pharmaceutical Services. The structure of the device is based on the SmartDose® technology platform, which is capable of providing an additional dose of Repatha. The device clings to the patient’s skin, leaving the hands free, since the drug is administered subcutaneously by the device. Patients can perform light daily activities, including walking and daily chores.

Repatha belongs to the PCSK9 inhibitor category. The mode of action is different from other statins in the market, including Pfizer’s Lipitor, Lescol by Novartis, and AstraZeneca’s blockbuster drug Crestor.

Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are clinically designed to control low-density lipoproteins (LDL), also called bad cholesterol. The inhibitors proved to be effective in clinical studies by lowering LDL to 60% in patients with high LDL-C. Praluent was the first PCSK9 inhibitor molecule approved by the FDA in 2015, which is developed and commercialized by Regeneron Pharmaceuticals Inc. and Sanofi SA. Amgen launched Repatha, which comprises the same portfolio, a month later.

Elevation in LDL-C levels is a common condition, directly affecting the level of cholesterol/fats in the blood, which leads to cardiovascular ailments. In the US, 11 million people suffer from either atherovascular cardiovascular disease (ASCVD), or familial hypercholesterolemia (FH), or both.