The U.S. Food and Drug Administration (FDA) plans to hold a meeting of its outside experts in June to discuss full approval of the Alzheimer's drug developed by Eisai Co Ltd and Biogen Inc , according to a federal filing on Monday.
accelerated approval by the FDA in January for patients in the earliest stages of the mind-wasting disease.
The U.S. health regulator grants the so-called accelerated approval based on data that show therapies are likely to work, and requires confirmatory trials later to give them full approval. In the large trial of Leqembi, which is given by infusion, the drug slowed the rate of cognitive decline in patients with early Alzheimer's by 27% compared with a placebo.
The FDA's independent advisers, who are scheduled to meet on June 9, will discuss the data from the study. Leqembi belongs to a class of treatments that aim to slow the advance of the neurodegenerative disease by removing sticky clumps of the toxic protein beta amyloid from the brain.
South Africa Latest News, South Africa Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Texas federal judge halts FDA approval of abortion pill mifepristone; Biden administration filing appealThe FDA approved mifepristone more than 20 years ago.
Read more »
Abortion Pill Ruling Could Threaten Vaccines, Contraception, Advocates SayAbortion rights advocates and former FDA officials warned that a federal court decision on medication abortion puts all other FDA-approved drugs at risk.
Read more »
Fetterman, Casey bash federal judge’s ruling against FDA-approved abortion medicationU.S. Sens. John Fetterman and Bob Casey blasted a Texas federal judge's ruling overturning the FDA's approval of an abortion medication that's been available for more than 20 years.
Read more »
FDA approves robotic bassinet to help keep babies sleeping on their backsAbout 3,500 infants die each year of sleep-related deaths.
Read more »