Leqembi authorization in EU is delayed for procedural issues
The EU review of Eisai’s Alzheimer’s drug lecanemab was delayed this week because of a procedural issue at the European Medicines Agency.
On Friday, Eisai said that a March 19 question-and-answer session on lecanemab at the Committee for Medicinal Products for Human Use (CHMP) didn’t end up happening because of a separate legal issue that came days before.
The delay is related to a court case between D&A Pharma and the EMA. The Court of Justice of the European Union’s ruling on the case from March 14 has “implications on EMA’s policy on the handling of competing interests of experts” in scientific advisory groups that provide advice to help evaluate drugs, according to Eisai.
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