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.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.