Setback for Biogen and Eisai
Biogen Inc (BIIB) and Eisai Co Ltd (ESALF, ESALY) faced an unexpected hurdle as the scheduled Oral Explanation on March 19 with the Committee for Medicinal Products for Human Use (CHMP) was postponed.
Implications of the Delay
The delay, attributed to procedural issues at the European Medicines Agency (EMA), has direct implications for the ongoing review process of lecanemab, a critical drug currently under evaluation by the EMA.
Review Status of Lecanemab
Lecanemab has been under EMA review since January 2023 for early Alzheimer’s disease with confirmed amyloid pathology.
Ruling Impact on SAGs
The postponement follows a significant ruling by the Court of Justice of the European Union on March 14, 2024, concerning the organization of EMA’s Scientific Advisory Groups (SAGs).
Need for Fresh Deliberations
As a result, EMA has annulled the advice given at the SAG-N meeting for lecanemab on March 11, 2024, signaling the need for a new round of discussions. However, the timing of the upcoming SAG-N meeting remains uncertain pending further updates from EMA.
Market Expectations
According to RBC Capital Markets analyst cited by Reuters, approval is now anticipated in the second half of 2024, contrasting with Eisai’s earlier expectation of a decision by June 30.
Stock Performance
BIIB shares are currently down 1.10% at $218.32 as of the last check on Friday.
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