The U.S. Food and Drug Administration (FDA) stated on Thursday that it is requiring an additional MRI scan for Alzheimer's patients receiving Leqembi (lecanemab), citing safety concerns over a rare but potentially fatal side effect.
Biogen Inc.’s (NASDAQ:BIIB) Leqembi, developed to slow the progression of Alzheimer's disease in patients with mild cognitive impairment or early-stage dementia, received FDA approval in 2023.
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The antibody therapy targets beta-amyloid plaques, protein deposits in the brain linked to the disease's progression.
By reducing these plaques, the drug aims to preserve cognitive function in its earliest stages.
Biogen said Leqembi's U.S. in-market sales of approximately $63 million represent a sequential growth of 20%.
The agency stated that an MRI performed before the third infusion could help detect amyloid-related imaging abnormalities with edema (ARIA-E), a condition characterized by brain swelling or fluid accumulation.
Current prescribing guidelines recommend scans before the fifth, seventh, and 14th infusions.
However, the FDA noted in its review that patient safety data support the need for earlier monitoring to identify ARIA-E sooner.
The condition is often symptomless but can lead to seizures, status epilepticus, and, in rare cases, death.
The FDA has formally updated Leqembi's prescribing information to reflect the new requirement.
Reuters noted that the FDA requires patients on rival Eli Lilly and Co.’s (NYSE:LLY) Alzheimer’s drug Kisunla to obtain a brain MRI before the second, third, fourth, and seventh infusions.
On Thursday, Prothena Corporation plc (NASDAQ:PRTA) shared results from the Phase 1 ASCENT clinical program in participants with early symptomatic Alzheimer's disease (AD).
PRX012 was associated with higher overall ARIA-E rates relative to FDA-approved anti-Aβ antibodies, making PRX012 less appropriate for the patients studied in the ASCENT clinical program.
Prothena called the ARIA-E profile in early symptomatic Alzheimer’s “non-competitive.”
Price Action: BIIB stock is up 0.32% at $133.08 during the premarket session at the last check on Friday.
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