Biogen, Inc. BiIB and Eisai Co. Ltd. announced late Tuesday that they had good results from a late stage study of their late-stage 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.
The primary endpoint of the treatment with lecanemab was to reduce clinical decline by 27% on the global cognitive and functional scale at 18 months, compared to placebo, which is the primary endpoint. That was statistically significant in the analysis of the intent-to- treat population.
Attention Biotech Investors: Mark Your Calendar For September PDUFA Dates
Why is it important that Aduhelm has not been a commercial success because of limited coverage by Medicare, which was already receiving the Food and Drug Administration's nod for treating Alzheimer's.
The Centers for Medicare and Medicaid Services apprehensions regarding blanket coverage stemmed from poor data that supported approval of the treatment. The agency wanted to make sure that the data gathered confirmed the efficacy and value proposition of the drug, so the coverage was limited to participants of the trial.
Aduhelm is now priced at $28,000 a year for a person of average weight, defined as 74 kg. In the second quarter, Biogen earned a profit of only $100,000.
SVB Leerink analyst Marc Goodman said Phase 3 data would prove that amyloid is a key component of Alzheimer's.
He said that there were no new safety signals and that there were no new amyloid-related imaging abnormalities ARIA adverse events.
Goodman expects Biogen shares to shoot up by 20 -- 25% on the data, given the low expectations coming into the data readout.
What is next: Eisai 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 January 6, 2023.