Eisai applies for approval of its AD drug lecanemab in KOR

Delays cognitive decline by 27% compared to placebo

Expected to bring over KRW 1 trillion a year in 5 years

Pic of lecanemab

The drug that is being considered the next blockbuster candidate, Eisai and Biogen’s Alzheimer’s treatment ‘lecanemab,’ is set to enter the Korean market.

 

Eisai announced on the 8th that it had submitted an application for the marketing authorization of lecanemab to the Ministry of Food and Drug Safety to treat mild cognitive impairment or mild dementia stage of disease arising from Alzheimer’s disease (AD).

 

This is the third application the company had filed in Asia after Japan and China.

 

Lecanemab was jointly developed by the two companies.

 

Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD.

 

The drug received accelerated approval from the U.S.

 

Food and Drug Administration in January.

 

As Eisai applied for formal approval, the FDA plans to hold an advisory committee on the 9th (US local time) and decide whether to grant approval next month.

 

Unlike 'Aduhelm (ingredient: aducanumab)', which failed commercialization, high expectations are in place for lecanemab’s growth into a blockbuster drug.

 

Clarivate, a global academic information service company, predicted that lecanemab’s sales would reach USD 1.02 billion (KRW 1.32 trillion) in 2027 in its ‘Drugs to Watch’ report that it released earlier this year.

 

Eisai’s application to the MFDS is based on the Clarity AD Phase III and Phase IIb clinical studies that confirmed that lecanemab reduced clinical cognitive decline in early Alzheimer's disease.

 

The Phase III Clarity AD compared lecanemab with placebo in 1.705 patients aged between 50 to 90 with early AD.

 

The primary efficacy endpoint was the change in clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months.

 

Key secondary endpoints were ▲the AD Assessment Scale-cognitive subscale14 (ADAS-cog14), ▲change from baseline at 18 months compared with placebo of treatment in amyloid levels in the brain measured by amyloid positron emission tomography (PET), ▲AD Composite Score (ADCOMS), etc.

 

Change in CDR-SB score with lecanemab -placebo (primary endpoint) (data: Biogen)

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.

 

This delay started as early as six months.

 

The drug also achieved statistically significant in its key secondary endpoints compared with placebo.

 

In the amyloid PET subgroup analysis, the lecanemab arm showed a statistically significant reduction in brain amyloid accumulation from 3 months.

 

The ADAS-Cog14 evaluation results showed that cognitive decline was delayed by 26% with lecanemab.

 

ADCOMS results also showed a 24% delay in disease progression at 18 months with lecanemab.