Amgen: FDA Approves Update To IMDELLTRA Prescribing Information, Cuts Monitoring Time For Two Doses

(RTTNews) - Amgen (AMGN) announced the FDA approved an update to the IMDELLTRA Prescribing Information that substantially reduces the recommended monitoring time for the first two doses of treatment in an appropriate healthcare setting. This means that patients receiving IMDELLTRA should now be monitored for 6 to 8 hours from the start of their first two infusions, compared with the previously recommended 22 to 24 hours. Jay Bradner, executive vice president, Research and Development, Artificial Intelligence and Data at Amgen, said: "Reducing monitoring to 6-8 hours for the initial doses may help address practical barriers associated with administering IMDELLTRA and enable more patients to receive care closer to home.