Eisai's
drug for Alzheimer's with Biogen gets breakthrough status in U.S
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[June 24, 2021]
(Reuters) -Japanese company Eisai Co and
partner Biogen Inc said on Wednesday the U.S. Food and Drug
Administration had granted breakthrough therapy designation to their
experimental therapy, lecanemab, for patients with early Alzheimer's.
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The drug works in a similar manner to Biogen's Aduhelm, which was
approved earlier this month. It removes sticky deposits of a protein
called amyloid beta from the brains of patients in the earlier
stages of Alzheimer's in order to stave off its impact, including
memory loss and the inability to take care of oneself.
Eisai completed enrollment in March in a pivotal 18-month study of
lecanemab in symptomatic early Alzheimer's patients.
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Lecanemab is also being studied in a large trial on people with
evidence of amyloid in their brains, who do not yet have symptoms of
the disease.
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 The FDA grants breakthrough
therapy designation in order to expedite the
development and review of medicines for serious
or life-threatening conditions.
(Reporting by Dania Nadeem in Bengaluru;Editing
by Vinay Dwivedi)
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