The U.S. Food and Drug Administration (FDA) has approved the first combination product that incorporates West Pharmaceutical Services, Inc’s SmartDose® technology for use in the United States. Amgen announced FDA approval for a single, monthly 420 mg dose delivery option for Repatha® (evolocumab), utilizing the SmartDose technology, on Monday, July 11.
“West is very pleased that Amgen has selected the SmartDose technology platform for the new monthly single dose administration option of Repatha,” said Eric M. Green, President and CEO of West. “The combination of Amgen’s innovative treatment with West’s patient-focused technology platform is an example of how West closely collaborates with our pharmaceutical and biotechnology partners to deliver advanced, integrated solutions for drug delivery and containment.”
West’s SmartDose technology platform allows patients to self-administer medication in accordance with their prescribed treatment. West developed the SmartDose technology platform with extensive human factors testing and analysis to understand the interaction between the patient and the delivery system. The SmartDose technology platform adheres to the patient’s body, usually on the abdomen, so patients can be hands free during administration. The SmartDose technology platform is an integrated solution of delivery and containment featuring a silicone-free Daikyo Crystal Zenith® cartridge and a Flurotec® coated piston containment system.