The outlook on FDA approved new drug called Aducanumab for the treatment of Alzheimer’s disease. It is a monoclonal antibody target the basic pathology cause for Alzheimer’s disease
Aducanumab is a new drug for treatment of Alzheimer’s disease approved by FDA on 7 June 2021. It is a monoclonal antibody, one of the first disease modifying agents, that target the basic pathology or the hypothesised cause for Alzheimer’s disease.
It has got conditional FDA’s accelerated approval that means the company has to conduct another, may be so called phase IV clinical trial to verify the benefits. FDA can withdraw the drug if the trial fails to show clinical benefit.
For clinician like me, it is an exciting news of a drug approved for Alzheimer’s disease after nearly two decades, and first one targeting the pathology. I would eagerly wait for results of next suggested trial as FDA put it, before discussing the option with the clients. I would also be concerned over the pricing as it is anticipated to cost $56000 per year for package of recommended 14 treatments.
It is given Intravenous infusion approximately 4 weeks apart. Dizziness, confusion, headache & also hypersensitivity reactions are reported as adverse effects of this drug.
As per reports, this Monoclonal antibody targets and clears out the amyloid beta plaques & reduces it’s deposition, thus reducing the toxicity to the nerve cells. The studies found apparently significant reduction in the amount of Amyloid plaques compared to controls based on the PET Imaging studies. When the plaque deposits reduce, toxicity reduces, and so the cells do not degenerate & therefore available to function. Therefore one may expect reduced or less likely of the progression of the illness if it is successful in significant reduction in plaque deposits.
Previously in last 3 years, unfortunately, at least two similar monoclonal antibodies failed to show promising efficacy was disappointing. We eagerly hope it is going to make significant reduction in morbidity & reduces caregiver stress.
Dr. Vijay Kumar Harbishettar
MRCPsych, EX NIMHANS
NHS, Consultant Psychiatrist at Samvedna Senior Care
This is exciting development, this is the first medicine approved in 15 years. The available Treatment of Alzheimer’s has been insufficient in modifying the disease course. This medicine gives us a chance in theory, to reverse some of the causes of the disease.
It is still not available in India but we will have to keep looking at data that comes out of America to look at its efficacy and side effects.
Dr. Vipul Rastogi,
MRCPsych, Neuro Psychiatrist
EX NHS, Advisor Samvedna Senior Care.
