Atopic dermatitis drug Ebglyss to enter Korea next year

Ebglyss, the 3rd biologic for atopic dermatitis is set to be released to market without reimbursement

Other competitors suffer reimbursement hurdles…hopes are on HIRA’s approval of the JAKi-biologic switching administration approval

Lilly applies for Ebglyss’s reimbursement upon its approval, when it enters the market will serve as the key to its competition

The atopic dermatitis drug Ebglyss (lebrikizumab), which is set to soon be released in Korea, has added competitivity by securing rationale for switching between biologics.

 

The company plans to receive reimbursement after launching the drug without reimbursement early next year.

 

Pic of Ebglyss

At the recent Fall Clinical Dermatology conference that was held in the U.S., Lilly presented results from the ADapt Phase IIIb study, which confirmed the effectiveness of Ebglyss in patients with moderate-to-severe atopic dermatitis who were previously treated with Dupixent (dupilumab).

 

Patients in the ADapt study were those who discontinued Dupixent due to insufficient response, intolerance, adverse events, or other reasons (e.g., burden of cost, loss of access to treatment).

 

Results showed that among patients treated with dupilumab, the proportion of patients achieving an Eczema Area and Severity Index (EASI) of 75 after treatment with Ebglyss was 57% at Week 16 and 60% at Week 24.

 

In addition, among patients who had an inadequate response to sarilumab, 46% achieved an EASI-75 at Week 16 on Ebglyss.

 

These results were similar to those observed in two Phase III studies (ADvocate 1 and ADvocate 2) which evaluated the clinical utility of Ebglyss monotherapy in dupilumab-naïve patients.

 

This confirms its competitive advantage, particularly as an alternative option for atopic dermatitis patients who have not responded to Dupixent, which owns the largest share of the atopic dermatitis treatment market.

 

According to the drug research institution IQVIA, Dupixent generated KRW 105.2 billion in sales in 2022, but last year's pediatric reimbursement expansion led to a significant increase in sales to KRW 143.2 billion.

 

In Q1 this year, the drug generated KRW 40.5 billion in sales, with further sales growth expected.

 

Currently, Lilly Korea has applied for Ebglyss’s reimbursement in Korea.

 

However, due to the time required to review its reimbursement, the drug will first be launched without reimbursement early next year.     However, it is expected that the drug’s reimbursement approval will be a top priority for Lilly to enter the market even after the launch of Ebglyss, as it is difficult to penetrate the market due to the fact that several therapies, including Dupixent and JAK inhibitors, have received reimbursement.

 

What Lilly is looking forward to is the possibility of allowing switching between treatments in severe atopic dermatitis.

 

According to industry sources, HIRA established the standards for switching between biologics and JAK inhibitors through expert discussions in September.

 

Although the follow-up procedures such as negotiations with the NHIS are scheduled, the fact that discussions have been initiated is receiving positive evaluations.

 

“Due to the nature of severe atopic dermatitis, there are patients who cannot see an effect with currently available treatments, so I think there will be a demand to use Ebglyss,” said a professor of dermatology at University A Hospital.

 

”There is a positive trend for switching, but Ebglyss is not yet reimbursed, so it will be important to see whether it will be reimbursed in the future.”