After twenty years of silence, the American FDA today approved the first drug against Alzheimer’s, Aducanumab, trade name Aduhelm. An approval not taken for granted, given the doubts of some experts and even the contrary opinion of the independent committee of the agency, according to which there is not enough evidence that the drug can really help patients.
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So talking about a turning point is perhaps still impossible even if it is equally true that the FDA certainly does not approve a drug with a light heart, especially if there are enormous expectations of patients and families all over the world behind it. The drug, Aducanumab, is the first specifically approved to counter the degenerative process of the disease and not its symptoms.
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A few details: it is administered with a monthly infusion in the vein and should slow down the cognitive decline in the early stages of the disease, with still a memory, albeit not intact, and some cognitive problems. And it would add an extra piece to the early diagnosis, which is being developed thanks to some biomarkers but which made little sense in the absence of any therapeutic intervention.
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The FDA admitted that the submitted studies did not provide complete evidence of efficacy and therefore approved the drug on the condition that the company that developed it – Biogen – conducts a new clinical study. In the years it will take for the study to be completed, the drug will still be available to patients, the agency specified. And if the post-market study, the so-called Phase 4, fails to prove the drug’s efficacy, the FDA will revoke the approval.
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