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Repatha Monthly Dose Approved With On-Body Pushtronex System

 
• By Jessica Merrill

Amgen’s PCSK9 blocker was cleared by FDA at a 420mg dose that can be administered once monthly via a hands-free device, offering a point of differentiation versus Sanofi/Regeneron’s Praluent.

Amgen Inc.’s PCSK9 inhibitor Repatha (evolocumab) has been approved by FDA in a new once-monthly dose that could help to differentiate the product from Sanofi/Regeneron Pharmaceuticals Inc.’s Praluent (alirocumab).

The new higher dose is administered through the Pushtronex system, an on-body infusor with a prefilled cartridge that administers the drug delivered subcutaneously over the course of nine minutes. Amgen...

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