- Amgen said Monday the Food and Drug Administration had approved a device to deliver its new PCSK9 drug Repatha by a once-monthly injection, giving the drugmaker a more convenient dosing option to market as it battles PCSK9 rivals Sanofi and Regeneron.
- Repatha is typically administered through 140-mg injections every two weeks. The newly-approved “Pushtronex” device allows for hands-free subcutaneous administration once a month.
- Repatha, along with Sanofi and Regeneron’s Praluent, have had slower-than-expected launches despite positive clinical data. Both are pricey, which has led to payer pushback on coverage.
Repatha was approved in the U.S. as a treatment of adults with a hereditary type of high cholesterol (known as familial hypercholesterolemia) or atherosclerotic cardiovascular disease.
Patients are given the drug through 140 mg injections every two weeks or a series of three injections given once a month.
The new device delivers the injection through an on-body infusor with a pre-filled cartridge of Repatha, allowing patients to be moderately active while receiving the treatment.
For patients, the device is a more convenient dosing option, which typically helps boost compliance.
While it appears Amgen is looking for any edge to improve uptake of Repatha, the drug’s $14,100 annual list price could still cut into payers’ willingness to cover treatment.
For the first quarter of 2016, Repatha generated $16 million in sales, while Praluent pulled in $14 million. Both companies have brokered pay-for-performance deals in hopes of winning better payer coverage.
While more convenient dosing options should help on the margins, the real boon for both drugs would be clinical data linking treatment to decreased risk of cardiovascular morbidity and mortality.