Alzheimer's - hope for those affected?
Zurich, Switzerland, 31 July 2021
The approval of Biogen's aducanumab by the FDA last month marked the first new disease modifying Alzheimer's drug to be okayed for patients in almost 20 years. Some have hailed the decision as a historic moment in the fight against a devastating, incurable disease – but the move is not without its controversy.
Alzheimer's is the most common form of dementia in the elderly, affecting tens of millions of people worldwide. It is suggested that it is caused by deposits of proteins, called amyloid plaques, in the brain that accumulate over years and damage neurons. It results in progressive memory loss and impairment of learning, orientation, language and planning abilities.
The aducanumab antibody, was discovered and developed by researchers at the University of Zurich's Institute for Regenerative Medicine and the Zurich-based biopharmaceutical company Neurimmune.
While doctors, patients and the organisations that support them are desperate for treatments that can slow mental deterioration, the usefulness of the new drug, aducanumab, is disputed by scientists. Two trials were stopped in March 2019 because the drugs appeared not to work. The manufacturer, Biogen, said the drugs were unlikely to improve people's memory and thinking.
But the company announced 7 months later that a reanalysis of more patient data from one of the trials involving people who had taken the drugs for longer showed that a high dose could slow the decline of memory and thinking skills and the ability to carry out activities in daily life.
Biogen Defends Newly Approved Alzheimer's Drug.
It is unique that the US regulatory authority narrowed the label to the investigated patient group in the trial only after they initially approved Aduhelm just one month ago with a surprisingly broad label for all Alzheimer patients, "says Dr Michael Nawrath, managing partner health care and pharmaceutical analyst at Strategic Swiss Partners. "What is historically unprecedented in addition is that the FDA commissioner J. Woodcock by herself induced an investigation of the whole approval process by an independent body regarding relationships between FDA decision makers and Biogen's manager."
Now everything is possible. "In the worst-case scenario for Biogen, the FDA withdraws the approval or suspends it until new data are available," says the expert. The approval studies had shown that Aduhelm had the effect of reducing protein deposits in the patient's brain. But there is still no evidence that this also improves the patients' cognitive abilities.
Millions are at stake for the University of Zurich.
According to earlier information from Biogen, the Swiss spin-off receives a share of sales of 8 to 12 percent. The University of Zurich should get around 2 percent. With the Alzheimer's drug, there are millions at stake for Neurimmune and for Zurich University. Even with the narrower approval for patients with early symptoms, expert Nawrath estimates the sales potential of Aduhelm per year at 7 to 10 billion dollars, however, with a slow start due to the uncertainties on doctor's and insurer's side. These uncertainties are mainly caused by the lack of clinical evidence and the huge price tag of annual treatment costs of $ 56,000 per patient.
Neurimmune does not want to comment on the upcoming review of the approval process because the spin-off was not involved. The company believes that it makes sense that the FDA has restricted the use of the agent to patients with early symptoms. Because the FDA wants to use the drug in the patient group who previously participated in the approval study.
How long the external review of the FDA's approval process will take is unclear. FDA boss Woodcock hopes that it will be "as soon as possible".