Ruminations: Awaiting Alzheimer's Brain Untangling Drug : Second Time Around

"People affected by Alzheimer's have waited a long time for a life-changing treatment and today's announcement offers hope that one could be in sight." "It is reassuring that this devastating disease remains a priority concern for drug regulators and with no disease-modifying Alzheimer's drugs getting this far before, we are in uncharted territory." Samantha Benham-Hermetz, director, policy and public affairs, Alzheimer's Research UK
"[Approval of the drug would be a] historic milestone." "Reducing clinical decline and maintaining the ability to live an independent life for as long as possible are things that people living with Alzheimer's and their families value in a potential treatment." "If aducanumab is approved, we expect it will make a difference in the lives of people living with Alzheimer's." Haruo Naito, chief executive, Eisai, Japanese pharmaceutical firm

Alzheimer's drug passed Phase 3 clinical trials now awaiting FDA approval

Back in 2019 manufacturers Biogen and Eisai took steps to put an end to two late-stage Alzheimer's drug trials, making the tough decision to set aside plans that the treatment be developed. Studies had indicated the treatment would be of no benefit to Alzheimer's sufferers. A new analysis has been undertaken since then using a greater amount of data available once the trials were stopped, finding the drugs did indeed work. They had to be administered at an early stage in a sufficiently high dosage to be effective, leading the two drug developers to seek approval a second time.

Alzheimer's disease at the present time is without any kind of truly effective treatment. A cure may be possible, but it may also be a long way into the future. Now, however, experts feel that the first drug that may halt Alzheimer's, will be fast-tracked for approval, representing the most hopeful breakthrough in dementia treatment yet devised. Because the drug is being given "priority review" it is possible that within six months it can be prescribed. Answering the hopes of those who suffer from the relentless mind-occluding disease.

Medicines currently prescribed for Alzheimer's do no more than mask the symptoms. The new treatment works by helping to untangle plaque clumps in the brain and in so doing may be the first successful drug to stop the deterioration the disease causes, according to trial results. Patients given aducanumab were seen to be improved in language skills and time-tracking, along with a more reduced loss of memory. Targeting early signs of dementa will lead to halting the progression of the disease; at the very least slowing its progress before total incapacitation.

The review is expected to take six months in establishing whether the drug is safe and effective, thus ushering it to licensing first in the United States, and then placing it under consideration elsewhere around the world. Its efficacy has been monitored by scientists around the world, following initially uncertain trial results.

Five months following the decision to halt the aborted trials, there is now enough confidence to allow the trials to continue, with the knowledge that a higher dosage and earlier application leads to aducanumab's treatment success. This is the first time in 17 years the U.S. Food and Drug Administration is preparing to review a drug for the treatment of Alzheimer's disease, and it would represent the first treatment designed to deter progression of the disease, to be approved by regulators.

Aducanumab is designed to untangle clumps of amyloid beta, the protein plaques which form in the brain, a hallmark of Alzheimer's disease. It is an anti-body drug. The plaques are held to be partially responsible for memory loss and cognitive decline. Chief executive at Biogen, Michel Vounatsos, a multinational biotech firm in Cambridge, Massachusetts stated: "We believe that aducanumab marks the beginning of a new era of potential treatments for Alzheimer's disease".