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Amgen's Repatha Gains FDA Approval for New Dosing Option

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Amgen Inc. (AMGN - Free Report) announced that the FDA has approved a new, monthly single-dose administration option for its PCSK9 inhibitor, Repatha. The Repatha Pushtronex system, an on-body infusor with a prefilled cartridge, is a hands-free device intended to provide 420 mg in a single dose.

Approval makes Repatha the first and only PCSK9 inhibitor to have a monthly single-dose delivery option.

We note that the recommended dosage of Repatha is either 140 mg every two weeks or 420 mg once monthly. The 420-mg monthly dosing requires three 140-mg injections to be administered consecutively within 30 minutes using the single-use prefilled autoinjector (SureClick) or syringe.

The latest approval will now provide patients with an additional and convenient dosing option.

Per Amgen’s press release, the device has been priced at $14,100 annually (wholesale acquisition cost), similar to the twice weekly administration. The company expects to launch the Pushtronex system in the U.S. early next month.

We are pleased with Repatha becoming the first and only one with a monthly single-dose administration, which could most likely give the company an advantage over its competitors.

We note that Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Sanofi (SNY - Free Report) are also looking to seek FDA approval for the once-monthly dosing regimen of their PCSK9 inhibitor, Praluent.

However, sales of both Repatha and Praluent are yet to pick up with the drugs facing a difficult access and reimbursement environment among other things. Nevertheless, positive cardiovascular outcomes data once available should help boost these drugs’ sales.

Amgen expects to report top-line data from its Repatha outcomes study in the first quarter of 2017. Moreover, Amgen received a favorable ruling in its patent infringement lawsuit against Regeneron and Sanofi related to PCSK9 inhibitors in Mar 2016.

Amgen is a Zacks Rank #3 (Hold) stock. Innoviva, Inc. (INVA - Free Report) is a better-ranked stock in the health care sector sporting a Zacks Rank #1 (Strong Buy).

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