New Alzheimer’s drugs are rare. Attacking the cause of the disease is even rarer.

Treat symptoms, and you will always treat symptoms. You must treat the cause of any disease (or any problem in life) to fix or cure it. A few drugs concentrate on the cause of a disease. Most treat the symptoms. This new Alzheimer’s drug targets one of the known causes of Alzheimer’s disease (A.D.)

Aduhelm

https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/aducanumab-marketed-aduhelm-information. The new drug, Aduhelm, is an antibody that targets the beta-amyloid protein. Scientists believe that if the levels of beta-amyloid are reduced, the symptoms associated with A.D. will be diminished.

Clinical trials have mixed results. The F.D.A. approved the drug based on mixed reviews.

Second New Drug for A.D.

https://www.newsmax.com/health/health-news/alzheimers-drug-treatment-fda/2021/06/25/id/1026432/. Donanemab, an A.D. drug from Eli Lilly, showed declining mental function in a recent clinical trial of nearly 300 patients with early-onset A.D. Additional clinical trials are ongoing and planned.

Donanemab was designated a breakthrough therapy by the F.D.A. since it is considered better than existing approved drugs for A.D. Like Aduhelm, donanemab focuses on the beta-amyloid protein. Approval of donanemab is expected by the end of this year.

Concerns

https://www.nytimes.com/2021/06/21/health/aduhelm-alzheimers-drug.html Some independent evaluations of the clinical trials report that Adhhelm does not slow A.D. progression. As such, the scope of clinical trials should be limited to a narrow group of A.D. patients.

The concern is centering around what are the ideal patients to benefit from this drug. Current protocols require monthly intravenous infusion and regular M.R.I. scans. One of the side effects of this drug is swelling (hemorrhaging) of the brain.

Clinical trials focused on A.D. patients with mild symptoms. The label for this drug surprises many under the topic of contraindications where the response is – none! Very astonishing! All medicines have side effects and contraindications.

Pricing an Issue!

https://www.fiercepharma.com/pharma/aduhelm-s-price-potential-popularity-could-be-tipping-point-for-drug-pricing-reform-analysts. The last A.D. drug was approved nearly twenty years ago. Aduhelm’s price is set at $56,000/yr. Analysts predicted between $10,000 and $30,000 annually. The Institute for Clinical and Economic Review (ICER) stated that the price must be between $2,500 and $8,300 to meet cost-effectiveness thresholds.

Conclusion

A.D. drugs appear to command significant prices. Will insurance companies cover a portion of that cost? Who can afford the drug otherwise?

Beta-amyloid protein plaque is one known cause of A.D. There are others. Treating the beta-amyloid plaque formation does not address the tau protein tangles also present in many A.D. patients.
It is a very sticky wicket to use high-priced drugs that temporarily extend an everyday life for months or many a year or two.

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