Biogen, Eisai get USFDA nod for Leqembi Iqlik Subcutaneous Injection for maintenance dosing for early Alzheimer's Disease

AD is a progressive, relentless disease with amyloid beta (Aβ) and tau as hallmarks, caused by a continuous underlying neurotoxic process that begins before amyloid plaque removal and continues afterward. Only LEQEMBI fights AD in two ways - targeting both amyloid plaque and protofibrils, which can impact tau downstream. Due to the reaccumulation of AD biomarkers and return to placebo rate of decline after therapy is stopped, maintenance treatment with once-weekly SC injection or once every four weeks of IV therapy offers patients options to continue slowing the disease progression and prolong the benefit of therapy, with the goal of helping patients maintain who they are for longer.

• In the Clarity AD core study, the mean change from baseline between the lecanemab IV once every 2 weeks treated group and the placebo group after 18 months was -0.45 (P=0.00005) on the primary endpoint of CDR-SB global cognitive and functional scale.
• To provide context, a change from 0.5 to 1 on the Clinical Dementia Rating (CDR) score domains of Memory, Community Affairs and Home/Hobbies reflects a shift from mild impairment to loss of independence. This can affect a person's ability to be left alone safely, recall recent events, participate in daily activities, manage household tasks, and engage in hobbies and intellectual interests.6, 7
• At 48 months of treatment through the Clarity AD core study and its OLE, data showed lecanemab demonstrated a reduction in cognitive decline measured by CDR-SB of -1.75 points compared to the expected decline observed in the Alzheimer's Disease Neuroimaging Initiative (ADNI)*2 cohort.
• Similarly, when benchmarked against the expected decline in the BioFINDER*3 cohort, lecanemab showed a reduction of -2.17 points measured by CDR-SB at the four-year mark.