Despite inconclusive clinical trials, the United States has given aducanumab the green light.
It is an authorization given lip service and after bitter debate, which surprises the medical community: aducanumab (Aduhelm) from the laboratory Biogen, a drug against Alzheimer’s disease, was approved Monday by the FDA ( US Health Products Agency). A marketing authorization in the form of a “Expedited approval”, indicates the FDA in a press release, which allows to authorize a drug aimed at a serious disease, for which there is no equivalent, and if the data allow to hope for an effectiveness. This decision goes against the advisory opinion issued in November by an independent scientific committee, which considered that the evidence of effectiveness was not sufficient.
Aducanumab attacks the amyloid protein; in patients, this forms plaques around neurons that prevent them from functioning normally. The data (not yet published), collected in three studies on nearly 3,500 patients,
This article is for subscribers only. You have 69% left to discover.
Subscribe: 1 € the first month
Cancellable at any time
Already subscribed? Log in