Biogen, Inc. BIIB and Eisai Co. Ltd. ESALY announced late Tuesday positive results from a late-stage study of their Alzheimer’s treatment candidate.
What Happened: Biogen and Eisai said the global Phase 3 confirmatory study, "Clarity AD," of 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 to treat mild cognitive impact due to Alzheimer’s. This class of medication functions by binding to the amyloid beta oligomers or other forms of amyloid, such as plaque, whose accumulation and deposition are widely considered to cause the disease.
Treatment with lecanemab reduced clinical decline on the global cognitive and functional scale by 27% at 18 months, relative to the placebo, which is the primary endpoint. That was statistically significant in the analysis of the intent-to-treat population.
Why It’s Important: Aduhelm, which had already received Food and Drug Administration's nod for treating Alzheimer's, has not been a commercial success due to limited coverage by Medicare.
The Centers for Medicare and Medicaid Services’ apprehensions regarding blanket coverage stemmed from the poor data that supported approval of the treatment. The coverage was limited to participants of the trial as the agency wanted to ascertain that the data gathered confirmed the efficacy and the value proposition of the drug.
Aduhelm is now priced at $28,000 a year for a person of average weight, defined as 74 kg. It fetched a revenue of only $100,000 for Biogen in the second quarter.
SVB Leerink analyst Marc Goodman said the Phase 3 lecanemab data would strongly prove that amyloid is a key component of Alzheimer's.
“And importantly, the incidence of amyloid-related imaging abnormalities (ARIA) adverse events was in line with prior data and there were no new safety signals,” he said.
Goodman expects Biogen shares to shoot up by 20-25% on the data, given the low expectations coming into the data readout.
What’s Next: Eisai said it will discuss the data with regulatory authorities to file for traditional approval in the U.S. and marketing authorization applications in Japan and Europe by the end of March next year.
The FDA accepted Eisai’s biological license application for lecanemab under the accelerated approval pathway and gave a prescription drug user fee act, or PDUFA, date of Jan. 6, 2023.
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