FDA approves Biogen’s controversial Alzheimer’s drug
‘Jungle’ Jack Hanna retiring from public life after heartbreaking diagnosis
Letters to the Editor — March 7, 2021
Alzheimer’s took my mom, but her dignity and love shone to the end
How drinking red wine and eating cheese could help your brain
The Food and Drug Administration on Monday approved Biogen’s controversial Alzheimer’s drug aducanumab — making it the first federally approved treatment for the disease in about 18 years.
The drug, which will be marketed as Aduhelm, is the first ever that US regulators say can treat the underlying disease and its memory-robbing effects, rather than just symptoms like anxiety and insomnia.
The approval could bring hope to the more than 6 million Americans living with the disease — although some doctors have said the drug won’t help all patients, particularly those with more advanced disease.
Meanwhile, other health professionals have said the evidence supporting the drug’s efficacy is limited.
The FDA’s own outside advisors in November said the data behind the drug wasn’t strong enough — and even criticized the FDA’s own staff for what it called an overly positive review.
“We are well-aware of the attention surrounding this approval,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said Monday in a statement.
“We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders,” she continued.
“With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review.”
Share this article:
Source: Read Full Article