Biogen, Inc. BIIB and Eisai Co.Ltd. ESALY announced late Tuesday positive results from a late-stage study of its Alzheimer’s treatment candidate.
What happened: Biogen and Eisai delivered the Clarity AD Phase 3 global confirmatory study lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results.
lecanemab, an anti-amyloid beta protofibril antibody, is being evaluated for the treatment of mild cognitive impairment due to Alzheimer’s disease. This class of drugs works by binding to amyloid beta oligomers or other forms of amyloid, such as amyloid. B. Plaque, the accumulation and deposition of which is generally considered to be the cause of the disease.
Lecanemab treatment reduced clinical decline on global cognitive and functional scales by 27% at 18 months compared to placebo, the primary endpoint. This was statistically significant when analyzing the intent-to-treat population.
See also: Attention biotech investors: mark your September PDUFA dates
Why it matters: Aduhelm, which had already received Food and Drug Administration approval for treating Alzheimer’s, was not a commercial success due to limited Medicare coverage.
The Centers for Medicare and Medicaid Services’ fears about flat-rate coverage stemmed from the poor data supporting the treatment’s approval. Reporting was limited to study participants as the agency wanted to ensure the data collected confirmed the drug’s efficacy and value proposition.
Aduhelm now costs $28,000 per year for a person with an average weight of 74 kg. It brought in just $100,000 in revenue for Biogen in the second quarter.
SVB Leerink analyst Marc Gutman said the phase 3 lecanemab data strongly proves that amyloid is a key component of Alzheimer’s.
“More importantly, the incidence of adverse events related to amyloid-related imaging abnormalities (ARIA) was consistent with previous data, and there were no…
