WASHINGTON (Sputnik) – The US Food and Drug Administration (FDA) said on Monday that it has authorised the use of the Aduhelm drug for Alzheimer’s disease, its first such approval in 18 years after it found the medication provided valuable therapies for dementia that outweighed the risks.
The FDA noted that approval is typically given for drugs likely to produce favourable outcomes when some uncertainty remains about their clinical benefits.
Aduhelm was the first novel therapy approved for Alzheimer’s disease since 2003 and was directed at the underlying pathophysiology of the disease, precisely at the presence of amyloid-beta plaques in the brain, the FDA said.
The FDA acknowledged the attention surrounding its approval of the drug in view of the fact the data submitted for review of Aduhelm was highly complex and the expert community had differing views on its benefits.
On average, a person with Alzheimer’s disease lives four to eight years after being diagnosed, but some patients have lived up to 20 years, the FDA noted.
Sourse: sputniknews.com
0.00 (0%) 0 votes
