Amgen Statement on Evolocumab Proactive Monitoring
In response to several media inquiries, Amgen issued the following statement.
There have been reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use and this is reflected in the labels of statins.
Consequently, Amgen has been proactively monitoring for cognitive impairment in the evolocumab program.
Similar to other companies developing PCSK9 inhibitors, Amgen has been in communication with the FDA, and we will continue to investigate the potential for cognitive impairment in our program.
As previously reported in our 52 week OSLER study, amnesia and memory/mental impairment were reported uncommonly (in less than or equal to 1% of patients in any group). As such, Amgen has not seen any such signal so far, and will continue to monitor for these events carefully.
Amgen does not anticipate any delay from this activity to our program.
Amgen will present Phase 3 data in over 4000 subjects at American College of Cardiology (ACC) later this month.