Biogen Seeks Approval For New Alzheimer’s Drug

Biogen is developing a drug to fight Alzheimer’s, a disease that scientists have struggled to treat for decades. U.S. outside advisors to the Food and Drug Administration (FDA) will review the drug aducanumab and are expected to reach a final decision by March 7th.

Biogen believes their drug aducanumab could be the first to treat underlying causes that lead to the disease. Studies have shown that the drug could treat patients with earlier stages of Alzheimer’s to allow independency for a longer period.

Aducanumab is an antibody that removes amyloid plaques from the brain, a technique attempted by many failed drugs. A common side effect is ARIA or swelling of the brain. While this side effect can be painful, it is often manageable. Patient advocates state that COVID-19 has increased the need for a drug as it has killed over 229,000 people and tens of thousands of those individuals were living in nursing homes.

Aducanumab has faced a troublesome path to approval. Last year clinical trials were stopped as results were showing the drug to be ineffective. One trial resulted in the slowing of cognitive and functional decline, the second failed to meet this goal, however it proved beneficial for a subset of patients who were given a high dosage for ten months. In March, a follow-up safety study opened to 2,400 people who had previously participated in trials of the drug.

Many researchers believe there is a need for further testing, while others disagree. Neurologist Dr. David Knopman of Mayo Clinic said, “Aducanumab’s efficacy as a treatment for the cognitive dysfunction in Alzheimer’s disease cannot be proven by clinical trials with divergent outcomes.”

Millions of Americans suffer from Alzheimer’s and look to Biogen’s drug in anticipation. Biogen faces pressure to release the drug as about 1.5 million could be candidates for aducanumab. If one third of the people suffering with Alzheimer’s were to receive treatment in one year, the company could bring in up to $36 billion annually. Biogen’s shares have increased about 45% and raised the companies market value drastically.

As Alzheimer’s disease continues to affect aging populations worldwide, Biogen works to create a drug to slow the cognitive dysfunction. Millions eagerly await approval from the FDA to begin treatment.