[Reporter’s View] New drugs for Alzheimer’s in development

"I felt like it was all a dream.

 

But I wasn't sure if I was young dreaming that I’m older, or I was old dreaming that I was younger.

 

I have Alzheimer's." This is what Hye-Ja Kim, acting as a dementia patient in the “The Light in Your Eyes” TV drama two years ago, said as she revealed her condition to her friends.

 

The drama gained much acclaim with the twist that the story depicted the world from an Alzheimer’s patient's view rather than being a common ‘time leap (time travel)’ story.

 

The most common cause of dementia among the 840,000 dementia patients over the age of 65 in Korea is Alzheimer’s.

 

The exact pathogenesis or cause of Alzheimer’s remains unknown, but it is being presumed that the condition is caused by Beta-amyloid and tau deposition.

 

One of the reasons why Alzheimer’s was feared was because no drug could fundamentally treat the disease, and only drugs used to improve cognitive function were available.

 

Countless global pharmaceutical companies had attempted to develop treatments to no avail.

 

With no treatment available, prevention was considered as the only option for Alzheimer’s.

 

However, the field has entered a new turning point this year with Biogen introducing a new treatment for Alzheimer's.

 

Biogen's 'aducanumab (product name: Aduhelm),' was approved by the US Food and Drug Administration, and Eli Lilly is also preparing for the approval and review of its ‘donanemab.' When approved, two new treatment options will suddenly be available in the 'impregnable' field of Alzheimer's disease.

 

Of course, many issues remain to be addressed despite the introduction of these new drugs.

 

Both Biogen and Lilly’s new drugs target beta-amyloid plaques and reduce beta-amyloid to improve Alzheimer’s symptoms such as cognitive function, etc.

 

However, the issue is that it is unclear whether beta-amyloid is the determining cause of Alzheimer’s.

 

Recent studies have shown that the tau protein may be the main cause of Alzheimer’s, which raises mixed opinions on what needs to be targeted to treat Alzheimer’s.

 

Also, the two new drugs will need to be further verified.

 

The FDA had granted breakthrough therapy designation to both drugs and accelerated approval for aducanumab in consideration of the lack of treatment for Alzheimer's.

 

Donanemab is also expected to go through the same accelerated approval process soon.

 

Drugs that are approved with the accelerated approval system can receive faster approval than through traditional review processes but needs to demonstrate their clinical benefit through a confirmatory trial.

 

Otherwise, their approval is revoked.

 

In particular, Biogen’s aducanumab needs to justify its approval through further clinical trials as its two Phase III trials showed mixed results.

 

On the positive side, the introduction of these new drugs has changed public perception.

 

Alzheimer’s is no longer considered unconquerable.

 

Pharmaceutical companies in Korea and abroad are eagerly racing to be the first to develop more and better drugs for Alzheimer's.

 

Just earlier last year, the COVID-19 outbreak brought fear to the whole world.

 

However, with the introduction of COVID-19 vaccines and the introduction of COVID-19 treatments soon to be expected, COVID-19 has now entered the realm of being 'manageable.' This is why countries are now gaining the courage to attempt to live ‘With COVID-19’ even if more than 2,000 patients are confirmed every day.

 

Awaiting the second new Alzheimer’s drug to come, I have faith that Alzheimer's will soon become manageable, as with COVID-19 and the many other crises that we managed to overcome.