European Medicines Agency Delays Approval Decision For Biogen-Eisai Partnered Alzheimer's Drug Lecanemab

Biogen Inc BIIB and Eisai Co Ltd ESALF ESALY faced a setback as the much-anticipated Oral Explanation slated for March 19 at the Committee for Medicinal Products for Human Use (CHMP) was postponed. 

This delay, attributed to procedural issues at the European Medicines Agency (EMA), has implications for the review process of lecanemab, a pivotal drug currently under EMA evaluation.

Also Read: Biogen Could Engage In $1B-$2B Deals To Fill Revenue Shortfall Gaps, Analyst Says.

Lecanemab has been under EMA review since January 2023 for early Alzheimer’s disease with confirmed amyloid pathology.

The postponement comes on the heels of 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). 

This ruling impacts EMA’s policy regarding the management of conflicting interests among experts, particularly SAG members. 

Consequently, EMA opted to nullify the counsel provided at the SAG-N meeting for lecanemab held on March 11, 2024, signaling the necessity for a fresh round of deliberations. 

However, the scheduling of the forthcoming SAG-N meeting remains uncertain, pending further updates from EMA.

Citing RBC Capital Markets analyst, Reuters noted that an approval is expected in the second half of 2024, versus Eisai’s expectation of a decision in the quarter ending June 30.

Read Next: Eli Lilly’s Donanemab For Alzheimer’s Hits FDA Speed Breaker, Biogen Stock Gains On Delayed Decision.

Price Action: BIIB shares are down 1.10% at $218.32 on the last check Friday.

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