Latest news

• FDA grants Priority Review for Biogen and Eisai’s lecanemab for early Alzheimer’s disease

  The FDA’s approval for review follows its acceptance of the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab, which was completed in early May 2022. ... It has been agreed by the FDA that the results of Clarity

• Biogen and Eisai announce FDA submission for early Alzheimer’s treatment

  Biogen and Eisai have announced the rolling submission to the US Food and Drug Administration (FDA) for a Biologics License Application (BLA) for lecanemab. ... Results from the lecanemab phase 3 confirmatory ‘Clarity AD’ clinical trial, involving 1,

• Biogen’s Aduhelm unlikely to get approval in Europe

  Discussing Biogen’s prospects more widely, Abrahams said its Alzheimer’s franchise was “becoming increasingly dependent” on lecanemab.

• Eisai/Biogen present more data on antibody for Alzheimer’s disease

  Phase 2 data shows lecanemab offers a consistent ‘robust’ effect against Alzheimer’s disease, while the phase 3 programme will test plasma biomarkers to identify preclinical disease. ... with the Food and Drug Administration (FDA), after the agency

• Rolling submission granted for Biogen/Eisai's next Alzheimer’s antibody

  The FDA will review the data for Biogen and Eisai’s anti-amyloid beta protofibril antibody, lecanemab, on an ongoing basis. ... The lecanemab rolling BLA submission marks a new milestone toward the advancement of a treatment system for AD.”.