Amgen (NSDQ:AMGN) said today that a committee for the European Medicines Agency has recommended that the regulatory body approve a label variation for its Neulasta product to include the Onpro on-body injector delivery device.
Neulasta’s Onpro kit includes a pre-filled syringe paired with a single-use on-body injector. The lightweight device is given to the patient on the same day as their chemotherapy regimen.
Neulasta is designed to reduce neutropenia, abnormally low white blood cell levels, in adults taking cytotoxic chemotherapy.
“With more than 30 years of experience in granulocyte-colony stimulating factor (G-CSF) research, Amgen is committed to providing innovative solutions and developing new ways to improve the patient experience that also bring value to healthcare providers and health systems,” Dr. David Reese, SVP of Amgen’s translational sciences & oncology business, said in prepared remarks.
“The Neulasta Onpro Kit is a showpiece of our patient-centric approach and continued investment in advancing the field of G-CSF administration. This improved administration option not only provides patients with the freedom and independence they seek, but the optimally timed delivery gives peace of mind to physicians and caregivers knowing it helps fight the risk of infection.”
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.