Kuiken schreef op 5 april 2022 11:20:
Er zijn er meer bezig op VIVO's vlak: bron Alzheimer Today:
Biogen, the co-developer of Aduhelm (aducanumab) has submitted the final protocol for ENVISION — the Phase 4 post-marketing study of the therapy in early Alzheimer’s disease — to the U.S. Food and Drug Administration (FDA) for review and approval, the company has announced.
Screening of the first patient is expected in May, according to Biogen’s press release. The study will be completed within about four years.
The placebo-controlled ENVISION trial was a requirement by the FDA following its accelerated approval of Aduhelm in June 2021 for people with early-stage Alzheimer’s. Delivered as an into-the-vein infusion, clinical data showed that Aduhelm reduced amyloid-beta clumps in the brain, a hallmark of Alzheimer’s.
Under the accelerated approval, Biogen has nine years to market Aduhelm before completing the post-marketing study to confirm its clinical benefits.