Open in app

Aducanumab: Alzheimer's medication unapproved for usage in the European Union

img-1
Total Views:
58
img-1
Total Likes:
5
img-1
Published By:
Peeyush Ghalot
img-1
Published On:
21-12-2021

A new Alzheimer's disease medication has been rejected by the European Medicines Agency for use in the EU. Adults with early-stage symptoms do not seem to respond well to aducanumab. Alzheimer's organizations have expressed disappointment with the decision, claiming that thousands of patients are left with no alternatives. The medicine, the first novel therapy in 20 years, was met with skepticism. Even though it targets amyloid, a protein that produces abnormal clumps in the brains of patients with Alzheimer's disease, many experts at the time thought there was no evidence from studies that it was beneficial. Biogen, the drug's producer, has two weeks to file a reconsideration request to EMA. It's unclear whether the business would file a second application for clearance with the UK's Medicines and Healthcare Products Regulatory Agency (MHRA).

(Picture: - Medpage Today)

The European Medicines Agency concluded based on two significant trials that evaluated the effects of low dosage and a high dose of the medicine with a dummy tablet in over 3,000 individuals with early-stage Alzheimer's disease. After 78 weeks of therapy, the patients with moderate cognitive impairment or mild dementia were examined for their symptoms. The preliminary trials' findings were mixed, but they did not prove that aducanumab was beneficial in treating individuals with early-stage Alzheimer's disease. The EMA determined that the drug's benefits did not exceed its dangers and recommended that marketing authorization be denied. Nearly 8 million Europeans and around a million UK citizens project dementia, with numbers likely to quadruple by 2050.

Reference: - https://www.bbc.com/news/health-59699907