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U.S. regulators have approved a Biogen drug for Alzheimer’s disease that has split the scientific community, and this is an important moment for patients with the disease and their families.
Aducanumab is specifically designed for patients with mild to moderate Alzheimer’s disease. Biogen claims that it reduces the progression of the disease by breaking down the amyloid plaques that form in the brain.
Over the years, this therapy has been controversial, and many scientists have opposed approving it, saying it does not work.
The decision announced by the U.S. Food and Drug Administration on Monday is significant because in the past 20 years, no new drugs have been approved to treat this disease and there are few treatments. In the United States, nearly 6 million people suffer from Alzheimer’s disease.
The regulator admitted that its decision was controversial.
“We are well aware of the concerns surrounding this approval,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
She said the treatment was “very likely” to help patients, but added that the clinical benefits of the drug remained uncertain. In the end, the agency concluded that the overall benefits of aducanumab outweighed its risk to patients with Alzheimer’s disease.
The FDA’s own scientific advisory panel strongly opposed the approval of aducanumab last year, saying that Biogen’s trials did not prove that the drug was effective.
Cavazzoni acknowledged that there was a disagreement, but said that the drug removes amyloid plaques in the brain, which is “expected” to reduce cognitive decline in people with the disease.
The approval of the drug is fast because it meets the unmet need for serious diseases, and Biogen will need to conduct Phase 4 trials.
The Alzheimer’s Disease Association welcomed this decision, calling it a new day of hope for Alzheimer’s patients. “This approval is a victory for Alzheimer’s patients and their families,” said Harry Johns, president of the Alzheimer’s Association.
John Hardy, professor of neuroscience at University College London, said: “Although I am very happy that aducanumab has been approved, we must be aware that this drug is at best a meager drug and can only help very carefully selected patients.”
Biogen’s stock was suspended from trading before the decision, but the share price of the Japanese pharmaceutical company Eisai with which it partnered has soared 45%.
The FDA’s decision has had an impact on Alzheimer’s research outside of Biogen. Shares of Eli Lilly, which is currently trialling its amyloid-clearing drug, rose 10%.
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