No Fast Track For Lecanemab In EU Disappoints Eisai
Approval Could Come March 2024
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.
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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.
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.
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.