No Fast Track For Lecanemab In EU Disappoints Eisai
Approval Could Come March 2024
Executive Summary
Despite being hailed as a potential breakthrough for Alzheimer’s, the EMA will not fast-track lecanemab, underscoring differences with the FDA’s frequent use of accelerated pathways.
You may also be interested in...
Quick Listen: Scrip's Five Must-Know Things
In this week's podcast version of Five Must-Know Things: Merck & Co. tells Scrip oncology will remain a key priority; J&J is responsibly cautious on growth; Takeda pays big for HutchMed drug; industry looks at likely US IRA impact; and lecanemab misses out on EU fast-track treatment.
Lessons Learnt From Aduhelm, Eisai Is Preaching Patience On Alzheimer’s Drug Leqembi
Eisai has spent 25 years looking for a breakthrough in Alzheimer’s and warns that healthcare systems need to undergo a major shift to accommodate its breakthrough drug.
Closing The Books On Aduhelm: Congressional Report Leaves US FDA To Move Forward
A Congressional report on the US FDA approval of Biogen/Eisai’s Aduhelm generated another round of negative headlines for the agency – and rubbed salt in the wounds of a commercial disaster for the sponsors. But it probably could not have turned out better for FDA and the drug review climate overall.