Amgen Seeks FDA OK for Monthly Single Shot Repatha
This article was originally published in Scrip
Amgen is seeking the FDA's blessing to market a single-dose subcutaneous shot of its newly approved cholesterol-lowering drug Repatha (evolocumab) for patients who need the monthly dosage.
Repatha currently is available as a single-use 140mg/mL prefilled "SureClick" autoinjector or prefilled syringe, so patients who need the 420mg once-monthly dosage must get three injections consecutively over 30 minutes.
The new version would make it so those patients only need one single shot per month.
Repatha, a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor antibody, was approved by the FDA on Aug. 27 as an adjunct to diet and maximally tolerated statin therapy to treat adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C).
It also was approved with other LDL-lowering therapies, such as statins, Merck's Zetia (ezetimibe) or LDL apheresis, to treat patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.
In the primary hyperlipidemia with established clinical atherosclerotic CVD or HeFH, it was approved at the 140mg every two weeks or 420mg once-monthly dosage, while the HoFH was approved at the 420mg once monthly dosage.
"Patients who are in need of lowering their cholesterol levels are often on more than one medication and some may prefer a single-dose option for receiving Repatha once monthly," said Sean Harper, executive vice president of research and development at Amgen.
Repatha was the second PCSK9 inhibitor approved in the US – coming in a month after Sanofi's and Regeneron's Praluent (alirocumab), which was approved on July 24 for almost the same indications as Amgen's drug, except for the use in patients with HoFH, which is a more rare form of familial hypercholesterolemia that causes early onset of arthrosclerosis, often resulting in patients experiencing heart attacks in their early teens and dying before they reach 30.
Regeneron and Sanofi did not seek the HoFH use for Praluent.
But Steve Miller, CEO of PBM Express Scripts, said his company plans to "leverage" the competition between the two PCSK9 inhibitors "to achieve the greatest possible discounts for our clients and patients."
Last month, another big payer, CVS Health, said it would not negotiate with Sanofi and Regeneron on Praluent until the PBM got a look at Repatha's labeling. CVS, nonetheless, said it would expect patients to first try and fail statins before covering either of the PCSK9s.
To better compete, Amgen said it plans to work with payers and other purchasers to provide "innovative pricing programs," linking the net price of Repatha to the expected LDL-C reductions and anticipated appropriate patient use.
"By partnering with payers to implement these programs, we can help ensure that all appropriate patients who could benefit from Repatha will have access to this important new therapy," said Anthony Hooper, executive vice president of global commercial operations at Amgen.