GPP drug Spevigo can be prescribed in general hospitals

Expected to meet the unmet needs of GPP patients in Korea

Applied for special calculation, but remains non-reimbursable

'Spevigo', a treatment for Generalized Pustular Psoriasis (GPP), may now be prescribed in general hospitals in Korea.

 

According to industry sources, the new drug for generalized pustular psoriasis (GPP) from Boehringer Ingelheim Korea, Spevigo (spesolimab), has recently passed the Drug Committee (DC) of the Seoul National University Hospital.

 

Spevigo is a humanized antagonistic monoclonal antibody that binds to the IL-36R.

 

It prevents the subsequent activation of IL-36R and downstream activation of pro-inflammatory and pro-fibrotic pathways, providing a new treatment opportunity for GPP patients.

 

Generalized Pustular Psoriasis (GPP) is characterized by systemic inflammation affecting the skin and internal organs.

 

Its symptoms include diffuse erythema, fever, neutropenia, and skin pain.

 

Spevigo is the first drug approved for GPP in Korea, and the drug is approved as a treatment for adult GPP patients who experience rapid worsening of their conditions.

 

However, Spevigo is still not reimbursed in Korea.

 

Spevigo was approved in Korea in August 2023, but there has been no progress in discussions on its reimbursement to date.

 

As “generalized pustular psoriasis (KDC code L40.1)” has been included in the list of rare diseases eligible for special calculation since January 1 last year, there is also interest in whether the only treatment option, 'Spevigo', will be listed for reimbursement in Korea.

 

Meanwhile, the company is accumulating data on the efficacy and safety of Spevigo in GPP patients through the Phase II Effisayil-1/2 trial and the Effisayil-ON, a five-year open-label extension study (OLE), and the Effisayil-REP study for patients with recurrent exacerbations.

 

The results of the Phase II Effisayil 1 study, a 12-week clinical trial of 53 GPP patients who experienced flare-ups, showed that the percentage of patients who did not have visible pustules at the first week of treatment was 54% in the Spevigo group, compared to 6% in the placebo group, confirming the drug’s rapid elimination of pustules.

 

The percentage of patients with completely or almost clear skin (GPPGA score of 0 or 1) was also 43% in the Spevigo group and 11% in the placebo group, confirming the significant skin symptom improvement effect of Spevigo.

 

These effects of pustule removal and symptom improvement were consistent across all subgroups, regardless of gender, disease severity, race, or BMI.

 

In addition, the time to GPP flare was determined in the first and largest Phase IIb clinical trial, the Effisayil 2 study, which evaluated the efficacy and safety of GPP flare prevention in 123 patients with GPP aged 12-75.

 

The results showed that the high-dose Spevigo group’s flare improved by 84% compared to the placebo group.