Biogen Starts Approval Process for First Drug to Slow the Progression of Alzheimer’s Disease

Biogen Starts Approval Process for First Drug to Slow the Progression of Alzheimer’s Disease

The U.S. drug company Biogen has developed a revolutionary new drug which it claims can slow the progression of Alzheimer’s disease. All other treatments for this form of dementia work by alleviating the symptoms, but they do not slow or halt the progression of the disease.

Alzheimer’s disease is believed to be the most common form of dementia, a term given to a set of symptoms that include memory loss and loss of cognitive function as a result of physical damage to the brain. With Alzheimer’s disease, the nerve cells in the brain lose their connections to each other, which is believed to be due to the buildup of a toxic protein in the brain that forms structures called plaques or tangles. As the concentration of these protein plaques builds, it leads to cell death and tissue loss.

The new drug, Aducanumab, targets the amyloid protein that forms the toxic plaques and helps to clear these protein deposits. The drug cannot be considered a cure for Alzheimer’s disease, but by reducing the level of the toxic proteins, the progression of the disease is slowed. Biogen has reported that patients given the drug showed a significant reduction in clinical decline.

If the drug is approved for use, it would become the first drug to slow the progression of the disease and the first to show that by reducing the level of the amyloid beta protein, clinical outcomes can be improved.

If the drug was to be given to early Alzheimer’s disease patients, they would be able to continue to work, travel on their own, preserve their memory, and enjoy life for longer. The drug could dramatically improve quality of life.

Biogen stopped work on the drug in March 2019 following disappointing results in its Phase 3 studies. A futility analysis of its two studies conducted on 1,638 and 1,647 patients predicted the desired outcome would not be achieved; however, the company conducted a new analysis on a much larger dataset of 3,285 patients, 2,066 of whom had completed the 18-month study, which showed the drug worked in larger doses.

The new analysis confirmed the drug was pharmacologically and clinically active and effective at slowing the progression of the disease if it was administered in large doses. Even at the larger doses, the safety and tolerability were similar to previous studies of the drug at lower doses. The most common side effects were myloid-related imaging abnormalities-edema (ARIA-E) and headache, although in most patients, these resolved within 4-16 weeks and many patients did not experience symptoms during the ARIA-E episode.

“This large dataset represents the first time a Phase 3 study has demonstrated that clearance of aggregated amyloid beta can reduce the clinical decline of Alzheimer’s disease, providing new hope for the medical community, the patients, and their families,” explained Dr. Anton Porsteinsson, William B. and Sheila Konar Professor of Psychiatry, Neurology and Neuroscience, director of the University of Rochester Alzheimer’s Disease Care, Research and Education Program (AD-CARE), and principal investigator.

Biogen has been consulting with the U.S. Food and Drug Administration and will be preparing the paperwork and will be pursuing regulatory approval in the United States. Biogen plans to file the necessary paperwork in early 2020. Provided all is in order, it is likely to take around 1-2 years before the drug is approved. The company is also having a dialogue with regulatory authorities in Europe and Japan. If approved, Biogen will initially offer Aducanumab to patients who took part in its clinical studies.

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