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- Robert Nisticò and John Joseph Borg.
- School of Pharmacy, Department of Biology, University of Tor Vergata, Rome, Italy; Laboratory of Pharmacology of Synaptic Plasticity, Fondazione EBRI Rita Levi Montalcini, Rome, Italy. Electronic address: robert.nistico@uniroma2.it.
- Pharmacol. Res. 2021 Sep 1; 171: 105754.
AbstractOn June 7th 2021, the Food and Drug Administration (FDA) granted approval for Aduhelm (aducanumab) for the treatment of Alzheimer's disease under its accelerated approval program. Aducanumab is the first putative disease-modifying therapy (DMT) approved for the treatment of AD with a great potential for clinical benefit over current symptomatic therapies. The scientific community has been largely confounded by this historical decision since this has been based on the reduction of a surrogate marker (amyloid beta) and not on data showing clinical efficacy. Here we provide a regulatory perspective on the topic and discuss potential similarities and differences between the FDA's and EMA's evaluative processes.Copyright © 2021 Elsevier Ltd. All rights reserved.
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