The US Food and Drug Administration on Monday approved the first new Alzheimer’s drug in 20 years.
Officials ignored warnings from independent consultants that the long-debated treatment had not been shown to help slow the brain-damaging disease.
The US Food and Drug Administration said it granted approval for the drug, which was developed by the company “Biogene” for Alzheimer’s patients.
It is the only drug that US regulators have said is likely to treat the underlying disease rather than manage its symptoms such as anxiety and insomnia.
This approval decision, which could affect millions of older Americans and their families, is sure to stir disagreements among clinicians, medical researchers and patient groups, and has far-reaching implications for the criteria used to evaluate experimental treatments, including those that show only additional benefits.
The new drug, which was developed by “Biogen” in cooperation with the Japanese company “Esai”, did not stop mental decline, but rather slowed it down in only one study, and the drug is given in the form of an intravenous solution every four weeks.
The US Food and Drug Administration requires the drug company to conduct a follow-up study to confirm the drug’s benefits for patients, and if the study fails to show effectiveness, the US Food and Drug Administration can withdraw the drug from the market, although it rarely does.