A new drug that has shown hugely promising results in its ability to slow the progress of Alzheimer’s disease, the first to reach later phases of clinical trials, could be approved by as soon as next year. The most recent set of data from clinical trials of the biotech drug, aducanumab, showed patients demonstrated improvements in their memory and language skills. The FDA has confirmed aducanumab has been accepted for a priority review process, potentially fast tracking its approval.
Aducanumab is an antibody designed to target the enzymes that lead to the production of amyloid, a protein that builds up in the brain and has been heavily linked to Alzheimer’s. There is no definitive science that has yet explained a direct causal link between the build up of amyloid and the early stages of Alzheimer, but the level of correlation is convincing.
The FDA hopes to put the new drug through its review process in just six months, which would mean a decision by March next year. New drugs need regulatory approval before they can be made generally commercially available outside of clinical trials.
“People affected by Alzheimer’s disease have waited a long time for a life-changing treatment and today’s announcement offers hope that one could be in sight. “
“Importantly, the FDA will now accelerate the review of aducanumab to decide whether there is sufficient evidence that it is safe and effective to be made available in the US. It is reassuring that this devastating disease remains a priority concern for drug regulators. With no disease-modifying Alzheimer’s drugs getting this far before, we are in uncharted territory.”
Despite a growing but still far complete understanding of Alzheimer’s, aducanumab is the first drug for its treatment to be reviewed by the FDA in 17 years. The paucity of drugs offering real potential for progress in the treatment of one of humanity’s most devastating diseases means there is particular enthusiasm for the regulator’s show of urgency. Ms Benham-Hermetz added:
“At Alzheimer’s Research UK we will continue to highlight the need for regulators and drug developers to work together to speed up access to promising new treatments for those who need them. This critical work now has renewed urgency”.
“Covid-19 is putting dementia research at risk but our mission to bring about life-changing treatments has not changed. This government must now deliver on its manifesto commitment to double the dementia research budget to accelerate progress towards new treatments.”
U.S. biotech and pharmaceuticals firm Biogen has developed aducanumab but last year halted phase 3 clinical trials after early results indicated it would not benefit early-stage Alzheimer’s patients. However, a new analysis based on a larger volume of data became available after the trials had stopped, convincing Biogen to apply to the FDA for market approval. The Massachusetts-based biotechnology company will also submit a new study, based on re-offering the drug to eligible participants from earlier trials.
Drugs currently prescribed for Alzheimer’s treat the brain disease’s symptoms rather than underlying cause. Aducanumab strikes at the presumed source. Biogen chief executive Michel Vounatsos commented:
“We believe that aducanumab marks the beginning of a new era of potential treatments for Alzheimer’s disease.”