Leqembi’s EU Approval Process Delayed Over Advisory Group COI Considerations

The decision is not related to the product.

The EU regulatory agency’s discussions for lecanemab’s approval are hit by a decision to annul advice from an advisory committee due to the implications of a Court of Justice ruling on the handling of experts' competing interests.

The court ruling led EMA to void the SAG-N decision for Leqembi due to potential COI concern.
The court ruling led EMA to void the SAG-N decision for Leqembi due to potential COI concerns • Source: Shutterstock

The European approval process for Eisai Co., Ltd./Biogen, Inc.’s Alzheimer’s disease drug Leqembi (lecanemab) has been delayed due to the unprecedented impact from a recent court ruling related to the European Medicines Agency’s conflict of interest policy.

Eisai announced on 22 March that the EMA had annulled the advice it obtained from its Scientific Advisory Group on...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

England’s NHS Plan Eyes Cancer Vaccine Boost, Single Formulary & ‘Pay For Impact’ Drug Deal

 

The creation of a single national formulary for medicines prescribing that could impact industry is among the action points in the UK government’s new 10-year health plan for the National Health Service in England.

Denmark Sets New EU Benchmark With 14-Day Clinical Trial Review Timeline

 
• By 

Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

Lawyers Weigh In On ‘Sunshine’ Clause In EU Pharma Reform Package

 

The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.

More from Geography

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By 

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.