The U.S Food and Drug Administration has approved a new drug that could be the first to treat Alzheimer’s, one of America’s most debilitating diseases affecting 6.2 million Americans today!
The FDA is giving Aduhelm (aducanumab) accelerated approval status which can be used for drugs with serious or life-threatening illnesses when there is an available treatment that provides significant benefits over existing options. This may sound like good news but long-term trials are needed before it can confirm if this will provide clinical benefit to patients in need.
What is Alzheimer’s disease?
Alzheimer’s disease is a brain disorder that slowly destroys memory and thinking skills, eventually making it impossible for people to carry out simple tasks. Experts aren’t sure what causes Alzheimer’s but they know the symptoms are caused by changes in the brains of those who have this illness–particularly amyloid plaques and neurofibrillary tangles which cause neurons to die so connections between cells can no longer be made (which means memories cannot make their way into your mind).
How could Aduhelm help?
The newly FDA-approved treatment, Aduhelm is the first of its kind to successfully combat Alzheimer’s disease. It attacks the underlying problem for this complex condition through a completely new mechanism and has been shown in trials to increase cognition levels by an average of 30%. One study showed that it improved memory function over time when taken daily.
Aduhelm is an experimental drug shown to be successful as a treatment for Alzheimer’s disease in three separate studies. The first study found that patients receiving the medication had significant reductions of amyloid-beta plaque, while those on placebo did not experience any reduction at all; this was demonstrated again with two subsequent confirmation trials. These results show Aduhelm may have promise as a new way to treat Alzheimer’s and warrants further research into its potential benefits.
These results show the correlation between Aduhelm’s reduction of amyloid-beta plaque and its ability to combat Alzheimer’s disease. Measurements were taken via PET imaging which found that individuals who had higher levels of plaques in their brain also showed decreased cognitive function when compared with those with lower amounts.
Conclusion
The FDA is requiring Biogen to do a new randomized, controlled clinical trial in order for the accelerated approval requirements to be upheld. If this doesn’t happen and they fail then there’s a chance that their drug will lose its approvals altogether.
Aduhelm, a drug from Biogen of Cambridge, Massachusetts is made with the hope that it will help address unmet medical needs. The Fast Track designation seeks to expedite its development and review for this treatment to reach those who need it most as soon as possible.
