FDA approves new drug to treat Alzheimer's
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The FDA approved Leqembi, also known as lecanemab, just days after the agency was heavily criticized in a congressional report for its approval of another Alzheimer's medicine, Aduhelm.
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Signage is seen outside of the Food and Drug Administration (FDA) headquarters in the US. (Reuters)
The US Food and Medicine Administration authorized a long-awaited new drug aimed to reduce cognitive deterioration in Alzheimer's patients on Friday.
The FDA approved Leqembi, also known as lecanemab, just days after the agency was heavily criticized in a congressional report for its approval of another Alzheimer's medicine, Aduhelm.
In September, preliminary findings from a Leqembi trial revealed that it delayed cognitive loss in Alzheimer's patients by 27% over an 18-month period.
Leqembi and Aduhelm "represent an important advancement in the ongoing fight to effectively treat Alzheimer's disease," the FDA said in a statement as quoted by AFP.
The FDA authorized both treatments using an accelerated process, which allows the US regulatory agency to expedite the approval of drugs for serious illnesses with unmet medical needs.
Sources reported on December 30 that the 2021 FDA's approval of an Alzheimer's drug called Aduhelm was "rife with irregularities" as an 18-month congressional investigation found an "atypical collaboration" between FDA regulators and Aduhelm manufacturer, Biogen.
According to the probe, investigators found that the company intended to "make history" when it set an "unjustifiably high" initial yearly price of $56,000 for the drug.
This comes against the backdrop of criticism as the FDA is expected to decide on approving another drug for treating the disease in January.
The report also found that there was an unusually high amount of phone exchanges between company officials and FDA delegates.
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