α-GPC can't be replaced with other drugs in the field

[Interview] Ha Sangwook, head of the department of neurology at On Hospital in Busan

Despite the reduction in benefits, the prescription amount must be similar to before

Wait for the validation of Aducanumab

Apart from the steady increase in the number of patients over the past 20 years, there has been no significant change in dementia treatments used in Clinic sites.

 

However, two major changes have been predicted in the past two years.

 

One is the controversy over the preparation of Choline alfoscerate in Korea, and the other is the controversy surrounding Aducanumab, a new dementia treatment drug that has been released for more than 20 years.

 

The controversy is whether the drug is effective enough.

 

The solution to the controversy is quite similar.

 

Regulators in South Korea and the U.S.

 

have instructed the controversy surrounding the two drugs to properly verify their validity through "clinical re-evaluation." What do the front-line prescription sites think about these controversies?

 

Regarding the controversy over Choline alfoscerate, Ha Sang-wook, head of On Hospital, said, "It seems to help clinically improve cognitive function in early dementia," adding, "There will be positive results that re-verify the effectiveness of clinical re-evaluation." ◆ The prescription amount is similar to the previous one in reducing the benefit of Choline alfoscerate The core of the controversy is the effectiveness of Choline alfoscerate.

 

This is because drugs were recognized as medicines in Italy, where drugs were developed, while in other countries they were sometimes used as health functional foods.

 

In the end, the Ministry of Food and Drug Safety ordered a "clinical re-evaluation" last year to re-evaluate the safety and effectiveness of Choline alfoscerate on its own.

 

57 companies, including Daewoong Bio and Chong Kun Dang, have begun clinical re-evaluation.

 

The Ministry of Health and Welfare has reduced the benefit of the Choline alfoscerate.

 

Since August last year, when patients who have not been diagnosed with dementia use Choline alfoscerate, the drug price rate has risen from 30% to 80%.

 

Pharmaceutical companies have actively taken legal action.

 

Currently, a lawsuit for revocation of administrative disposition is underway.

 

Regarding the controversy over the effectiveness of Choline alfoscerate, manager Ha Sang-wook explained, "There are many studies that improve cognitive function when dementia or dementia drugs are not activated in the early stages." He said, "Clinically, when replaced with Choline alfoscerate from other drugs, it is observed that it leads to cognitive improvement." For this reason, he explained that despite the reduced benefit, the prescription amount is almost the same as before.

 

Manager Ha Sang-wook said, "First of all, it is a drug that patients are very satisfied with.

 

Even if the prescription is changed to another drug, it is often prescribed again as Choline alfoscerate, he said.

 

"I understand that it is prescribed steadily not only in our hospital but also in other places." He said there was no suitable drug to replace Choline alfoscerate.

 

He said, "Except for Choline alfoscerate, there is virtually no drug to prescribe to patients." He said, "In particular, in the case of vascular dementia, Donepezil is not applied, so it cannot be used.

 

Choline alfoscerate is the drug to be used, and if this drug is not allowed to be used, it is quite difficult for patients and doctors to use it, he said.

 

He was also optimistic about the results of clinical re-evaluation.

 

Manager Ha Sang-wook explained, "The key will be how many patients with hidden cognitive impairment are discovered." He said, "I think more patients with cognitive impairment will get good enough results if they participate in clinical trials.

 

The Dementia Association is also formed in a positive direction".

 

◆"Patients' interest in Aducanumab is increasing rapidly Expectations were high for the new dementia treatment "Aducanumab" recently approved in the United States.

 

In June this year, the U.S.

 

Food and Drug Administration (FDA) approved Aducanumab, co-developed by Biogen and Eisai, as a treatment for Alzheimer's dementia.

 

It has been about 20 years since Allergan's Namenda in 2003.

 

However, controversy over the validity of this drug has continued since the approval process.

 

Conflicting results were found in two clinical trials conducted by Biogen.

 

For this reason, the FDA Advisory Committee issued a non-approval recommendation in November last year.

 

The FDA did not accept the advisory committee's opinion.

 

However, in consideration of the controversy over its validity, the condition of "reevaluation after clinical trials" was attached.

 

Biogen should reevaluate Aducanumab through post-marketing clinical trials.

 

If the efficacy of Aducanumab is not proven in the re-evaluation, the approval will be revoked.

 

In terms of controversy alone, it is almost similar to the case of Choline alfoscerate in Korea.

 

Many patients ask a lot about this drug, he said.

 

"The success of Aducanumab will significantly change the direction of dementia treatment itself.

 

If proven effective, dementia will turn into a conquerable disease.

 

On the contrary, if clinical trials fail, follow-up drugs of the same mechanism are likely to fail, he said.

 

Since the approval of Aducanumab, several pharmaceutical companies have been developing drugs with beta-amyloid blocking mechanisms.

 

In June this year, Eli Lilly's "Donanemab" and "Lecanemab," co-developed by Eisai and Biogen, were designated by the FDA for breakthrough therapy designation one after another.

 

Both drugs are undergoing phase 3 global clinical trials.