The Food and Drug Administration said it granted approval for the drug developed by Biogen for Alzheimer’s patients. According to Sky News Arabia.
It is the only drug that US regulators have said is likely to treat the underlying disease rather than manage symptoms such as anxiety and insomnia.
Experts say the approval decision could affect millions of older Americans and their families, and could spark disagreements among doctors, medical researchers and patient groups.
The drug has far-reaching effects on 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 only slowed it in one study. The drug is given as an intravenous solution every four weeks.
The US Food and Drug Administration is requiring the drug company to conduct a follow-up study to confirm the drug’s benefits for patients.
If the study fails to show efficacy, the FDA could withdraw the drug from the market, although it rarely does.
Drug that slows dementia gives hope to millions
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