Will a new Alzheimer’s drug be introduced in 20 yrs in KOR?

2 drugs seek approval in Korea

Eisai applied for the approval of its lecanemab to MFDS in June

Multinational Phase III trial for Lilly’s donanemab also approved…makes way into Korea

New Alzheimer's disease treatments are accelerating their introduction into the country.

 

Following Eisai's application for the approval of its ‘lecanemab’ in June, Lilly also received approval from the Ministry of Food and Drug Safety to initiate a multinational Phase 3 clinical trial for ‘donanemab’ in Korea.

 

As Biogen applied to introduce 'aducanumab' to Korea in 2021 but withdrew its application for approval due to controversy over its effectiveness, attention is being paid to whether other new drugs may achieve success and make their way into Korea.

 

The MFDS approved Lilly’s Phase 3 clinical trial for donanemab on the 18th.

 

The trial will evaluate the safety and efficacy of donanemab inpatients with early symptomatic Alzheimer's disease.

 

Donanemab is a new antibody drug that blocks amyloid beta plaque accumulation, which is overexpressed in early-stage Alzheimer's patients.

 

The company submitted an application to the U.S.

 

Food and Drug Administration (FDA) at the end of June and is anticipating its approval at the end of the year.

 

In the Phase III trial results that were published in the Journal of the American Medical Association in July that observed the intermediate tau population, patients who were treated with donanemab showed that the drug slowed clinical decline by 35% compared to placebo.

 

A clinical trial that was conducted for 76 weeks also confirmed the effect of delaying the progression of Alzheimer's disease.

 

In the donanemab arm, 47% had no disease progression after 1 year, compared with 29% in the placebo arm After applying for FDA approval, the company also submitted data to Japan’s Ministry of Health, Labor and Welfare.

 

With the approval of this clinical trial, the company is expected to soon begin the approval process in Korea as well.

 

#iLilly had already applied for the approval of its ‘lecanemab,’ which has the same mechanism of action as donanemab, in June to treat mild cognitive impairment or mild dementia stage of disease arising from Alzheimer’s disease (AD).

 

The drug, which was co-developed by Eisai and Biogen, was officially approved by the FDA in July.

 

This is the third application the company has filed in Asia, following Japan and China.

 

Clinical trial results showed that the lecanemab arm recorded a CDR-SB score of 1.21 at 18 months, which is a 27% reduction in clinical decline compared with the 1.66 recorded in the placebo arm.

 

In Korea, no new drug for treating Alzheimer's disease has been approved since Ebixa (memantine) in 2003.

 

Aricept, the original drug of the ingredient donepezil, which is the most commonly prescribed treatment for Alzheimer's disease in Korea, received domestic approval in 2000.

 

The size of the domestic Alzheimer's disease treatment market is estimated to be near KRW 340 billion as of last year.

 

As it has already been 20 years since the first treatment was released, the companies of the 2 new drugs are expected to competitively accelerate entry into the domestic market for market preoccupation.