FDA Approves Amgen’s Repatha Pushtronex System
The FDA has granted approval to Amgen’s monthly, single-dose Repatha Pushtronex system.
The device is hands-free and delivers 420 mg of the PCSK9 inhibitor Repatha in a single dose. The treatment was approved by the FDA in August 2015 as the second PCSK9 inhibitor, days behind Sanofi and Regeneron’s Praluent.
The system’s development — which is based on the SmartDose technology platform — stems from a joint effort between Amgen and West Pharmaceutical Services. — Anisa Jibrell