After the death of six patients, the FDA has announced that it will require earlier and more frequent monitoring of the monoclonal antibody Leqembi, the brand name for the Alzheimer’s drug Lecanemab. Earlier this year the FDA issued a report identifying six deaths as the reason it immediately updated safety warnings for Leqembi.
Upon examination it was determined that the six deaths were related to amyloid imaging. The affected patients were also receiving either blood thinner medication or anti coagulants. Both procedures may increase bleeding in the brain.
The FDA’s updated safety recommendations now require earlier and more frequent MRI monitoring for patients taking Lequembi to identify ARIA sooner and prevent such outcomes.
Amyloid Related Imaging Abnormalities (ARIA) refers to any changes the researchers observe on MRI scans involving patients who have Alzheimer’s or patients with other similar conditions that involve the accumulation of amyloid protein.
Monoclonal antibodies (mAbs) are laboratory-produced proteins that closely resemble the body’s natural antibodies.
New Prescribing Information
The ruling applies to all Alzheimer’s patients who have received or who will receive Leqembi administered via IV infusion. The prescribing information must now include instructions for monitoring MRI somewhere between the 2nd and 3rd dose.
Initially, MRI monitoring took place one week prior to the fifth, seventh and 14th infusions.
However, basing its current decision on safety analyses, the FDA determined that one more MRI before giving the third dose is necessary and may identify recipients who have experienced imaging abnormalities that may be fatal.
The FDA reviewed 101 cases of severe ARIA-E. Twenty-four patients had serious ARIA-E that surfaced prior to the fourth dose. A review of the six deaths indicated that one patient was without symptoms initially (asymptomatic). The five remaining patients began to have symptoms prior to their most recent infusion leading to urgent MRIs.
The FDA stated that considering four of the fatalities occurred after the third treatment and the rapid onset of disease are indications that the process had already begun.
Lecanemab was FDA approved for Alzheimer’s disease in 2023.
