U.S. health officials have approved a closely watched Alzheimer's drug that modestly slows the disease, but could have potential safety risks that patients and doctors will have to carefully weigh.
— also from Biogen and Eisai — was"rife with irregularities," including a number of meetings with drug company staffers that went undocumented.
The FDA's approval was based on one mid-stage study in 800 people with early signs of Alzheimer's who were still able to live independently or with minimal assistance. "Most patients won't notice the difference," said Dr. Matthew Schrag, a neurology researcher at Vanderbilt University."This is really quite a small effect and probably below the threshold of what we'd call clinically significant."
About 13% of patients in Eisai's study had swelling of the brain and 17% had small brain bleeds, side effects seen with earlier amyloid-targeting medications. In most cases those problems didn't cause symptoms, which can include dizziness and vision problems.
France Dernières Nouvelles, France Actualités
Similar News:Vous pouvez également lire des articles d'actualité similaires à celui-ci que nous avons collectés auprès d'autres sources d'information.
FDA approves Leqembi, Alzheimer's drug that modestly slows diseaseALZHEIMER'S DRUG: The drug, Leqembi, is the first that’s been convincingly shown to slow the decline in memory and thinking that defines Alzheimer’s by targeting the disease's underlying biology. MORE:
Lire la suite »
US approves breakthrough drug Leqembi to treat Alzheimer'sLeqembi and Aduhelm, which were jointly developed by Japan's Eisai and Biogen of US 'represent an important advancement in the ongoing fight to effectively treat Alzheimer's disease,' says Food and Drug Administration.
Lire la suite »
Alzheimer’s drug that modestly slows disease OK’d by FDAThe drug, Leqembi, has been shown to slow the decline in memory and thinking that defines Alzheimer’s. But there are risks, including the need for infusions and the possibility of brain swelling.
Lire la suite »
Alzheimer’s drug that slows cognitive decline gets FDA approvalThe drug, lecanemab, removes a sticky protein from the brain called amyloid beta, which is thought to play a key role in the memory-robbing illness.
Lire la suite »
FDA Approves Alzheimer's Drug That Modestly Slows DiseaseThe drug, Leqembi, is the first that’s been convincingly shown to slow the decline in memory and thinking that defines Alzheimer’s.
Lire la suite »
FDA grants accelerated approval to Alzheimer's drug for people with early stage diseaseBREAKING: FDA grants accelerated approval to new Alzheimer's treatment that can slow cognitive decline in people with early stages of the disease.
Lire la suite »