GSK seeks reimb for self-injectable form of its asthma drug

GSK’s humanized monoclonal antibody, Nucala Autoinjector

Approved in March in Korea… launched without reimbursement in November

Added COPD indication…actively engages in activities to improve competitivity

The self-injectable formulation of the antibody drug ‘Nucala’ is aiming to enter Korea’s insurance reimbursement system.

 

GSK Korea recently filed for insurance reimbursement of its Nucala Autoinjector (mepolizumab), an anti-IL-5 (interleukin-5) antibody for treating eosinophilic diseases.

 

Nucala Autoinjector was approved in Korea last March and was released as a non-reimbursed drug this month after securing a distribution network and supply volume.

 

It remains to be seen whether Nucala, which has established its position in the field of eosinophilic asthma, can successfully secure reimbursement coverage for the new formulation upon its launch and expand its influence in Korea.

 

The new autoinjector formulation is approved not only for severe eosinophilic asthma in adults and adolescents (12 years and older), but also ▲ eosinophilic granulomatosis with polyangiitis (EGPA) in adults, and ▲ hypereosinophilic syndrome (HES) in adults.

 

This medication is a self-administered injection used to treat eosinophilic diseases.

 

It is indicated as add-on maintenance therapy in adolescents and adults aged 12 years and older with severe eosinophilic asthma (SEA), as add-on maintenance therapy in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), and as add-on maintenance therapy in adult patients with hypereosinophilic syndrome (excluding HES, FIP1L1-PDGFRα positive patients).

 

The autoinjector formulation enables patients to self-administer injections conveniently at home.

 

This is evidenced by a self-injection success rate exceeding 96%, high patient preference, and ease of use.

 

Meanwhile, Nucala has been enhancing its competitiveness by securing an indication for chronic obstructive pulmonary disease (COPD).

 

The drug obtained additional approval from the U.S.

 

FDA in May as an “add-on maintenance therapy for adult patients with COPD with an eosinophilic phenotype.” This approval was based on the results of the Phase III MATINEE and METREX studies.

 

In these studies, among a broad spectrum of COPD patients with an eosinophilic phenotype, the Nucala treatment group showed a significantly lower annual rate of moderate-to-severe exacerbations compared to the placebo group.