A drug against Alzheimer's disease that was presented as the first treatment for this degenerative neurological condition has been withdrawn from the market, according to what the American company that manufactured it, Biogen, announced on Wednesday.
In June 2021, the Food and Drug Administration in the United States approved this drug, called “Adohelm,” through accelerated procedures.
Her decision sparked controversy among the scientific and medical community because she violated the advice of a committee of experts who confirmed that the treatment had not been proven sufficiently effective during clinical trials.
Then a large number of committee members submitted their resignations in protest against the US administration’s decision. A parliamentary report also denounced the approval as “full of irregularities.”
-
Medication “Adohelm”
Biogen said it had halted production of Adohelm to allocate more resources to Liquimbe, a new Alzheimer's drug that was approved last year through normal procedures.
The new drug, whose active ingredient is lecanimab, belongs to a new generation of drugs that target beta-amyloid protein deposits.
The new drug has been tested in two human trials. Patients who took it in one of the two trials showed a reduction in their cognitive decline.
A 2022 parliamentary report noted that the FDA reviewed Adohelm in the “traditional” manner over a period of nine months, “before suddenly changing course and granting authorization under an accelerated approval process after a three-week examination period.”
#antiAlzheimer39s #drug #withdrawn #market #America
