On Monday, the government health officials approved a new drug to cure the Alzheimer’s disease after about 20 years, ignoring the warnings given by independent advisors who believe that the treatment has not proved to help slow down the underlying disease.
The FDA approved the Biogen-manufactured drug based on the research results that showed it appeared to reasonably benefit the Alzheimer’s patients. It is the only treatment that the regulators in US say can probably treat the brain-destroying disease than just managing symptoms such as insomnia and anxiety.
This decision, which might impact several Americans as well as their family members, is sparking disagreements among the medical researchers, patient groups and physicians. It has implications for standards utilized to analyse experimental therapies, which include those that have just incremental advantages.
The drug, which Biogen has developed with Eisai Co, didn’t reverse the mental decline, but just slowed it down in a study. The aducanumab medication will be sold as Aduhelm in the market and will be given like an infusion in every 4 weeks.
Meanwhile, Dr Caleb Alexander, who is an advisor to the FDA and disapproves the drug, said that he was very disappointed and surprised by the FDA decision.