news/BIIB/2023.01.20/Eli Lilly Alzheimer's drug setback extends rival Biogen's lead - analysts.txt

Jan 20 (Reuters) - The U.S. health regulator's rejection
of accelerated approval for Eli Lilly and Co's
Alzheimer's disease drug extends the market lead for rivals
Eisai and Biogen's treatment by months, analysts said.The U.S. Food and Drug Administration (FDA) declined to
approve donanemab because Lilly had not submitted data from
enough patients who were treated for at least a year, the
drugmaker said late Thursday."This is a modest positive for Biogen" because it delays
donanemab's launch, Jefferies analyst Michael Yee said, adding
that Eli Lilly could file for traditional approval by mid-2023.Lilly's shares fell 1.1% to $347.23 in premarket trading."Lilly's inability to launch donanemab near-term will
prevent them from expediting their launch post-full approval by
depriving them of the ability to begin to educate physicians and
patients," said Citi analyst Andrew Baum.The setback for Lilly comes just weeks after the FDA granted
Biogen Inc and Japanese drugmaker Eisai Co Ltd's
accelerated approval for their Alzheimer's drug
Leqembi.Analysts are waiting for the traditional approval of
Biogen's drug and for wider health insurance coverage before
they expect sales of the drug to pick up.Still, "we think, at minimum, it gives Eisai some extra time
on the market... to build a lead over donanemab", said Baird
analyst Brian Skorney.Lilly expects to report results from a confirmatory
late-stage trial of donanemab in the second quarter, which would
form the basis of the drug's application seeking traditional FDA
approval shortly thereafter."But if there is anything wrong with the (Eli Lilly) data
set, it is easier to reject an unapproved drug than remove an
approved drug from market," said Skorney.
(Reporting by Khushi Mandowara in Bengaluru; Editing by
Shailesh Kuber)