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 Aduhelm, which was approved by the U.S. FDA in June, works by
removing sticky deposits of a protein called amyloid beta from the
brains of patients in earlier stages of Alzheimer's in order to
stave off its ravages.
The drug, the first new treatment for the memory-robbing disease in
nearly 20 years, has been battling slow uptake since its approval as
experts have questioned the FDA's rationale for approving it without
more definitive proof of benefit.
The European Medicines Agency noted that although Aduhelm reduces
amyloid beta in the brain in studies, the link between this effect
and clinical improvement in the disease had not been established.
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 The results from the main
studies of the drug were conflicting and did not
show overall that Aduhelm was effective at
treating adults with early stage Alzheimer's, it
said.
Biogen will seek a re-examination of the
agency's opinion, it said in a statement.
Shares of Cambridge, Massachusetts-based Biogen
were down 4.2% at $225.58 in premarket trading.
(Reporting by Pushkala Aripaka amd Mrinalika Roy
in Bengaluru; Editing by Anil D'Silva and
Saumyadeb Chakrabarty)
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