Severe asthma treatment Fasenra seeks reimb in KOR

AstraZeneca starts the reimbursement listing process

Identifies improvement in asthma exacerbation rate and lung function in Phase III trial

Another severe asthma treatment is attempting insurance reimbursement in Korea.

 

According to industry sources, AstraZeneca is undergoing the reimbursement process for its monoclonal antibody for asthma, Fasenra (benralizumab).

 

Other biological drugs including GSK’s ‘Nucala (mepolizumab),’ and Teva-Handok’s ‘Cinqair (reslizumab)’ have also been reattempting reimbursement in Korea as well.

 

Fasenra was approved in Korea in 2019 as an add-on maintenance treatment in adults with severe eosinophilic asthma inadequately controlled with existing treatment options.

 

The drug is administered once every 4 weeks for the first 3 months, then every 8 weeks thereafter.

 

One of the main purposes of asthma management is to reduce the risk of asthma exacerbations.

 

Fasenra directly binds to the alpha subunit of the interleukin-5 receptor (IL-5Rα) to induce apoptosis.

 

The drug demonstrated efficacy in reducing asthma exacerbation and improving lung function.

 

In the global SIROCCO trial that was conducted to evaluate the effect of Fasenra in treating asthma exacerbations in 1,205 asthma patients including 122 Korean patients, the annual rate of clinically significant asthma exacerbations was reduced by 45% in patients who were treated with Fasenra once every 4 weeks, and by 51% in patients who were treated with Fasenra once every 8 weeks.

 

Also, in the CALIMA trial, Fasenra demonstrated a significant reduction in asthma exacerbations compared to the placebo.

 

In the trial, the annual rate of asthma exacerbations was reduced by 36% in patients who were treated with Fasenra once every 4 weeks, and by 28% in patients who were treated with Fasenra once every 8 weeks compared with placebo.

 

In both trials, a change from baseline in mean FEV1 (forced expiratory volume in 1 second) was observed using Fasenra, and a consistent improvement compared with placebo.

 

The long-term efficacy and safety of Fasenra in severe eosinophilic asthma were evaluated through the BORA trial, a long-term extension trial on 1,926 patients that participated in the SIROCCO and CALIMA trials.

 

In terms of safety, Fasenra showed no significant difference compared to the placebo, and 72% of the patients that were administered Fasenra did not experience asthma exacerbations and were able to maintain their FEV1.

 

Surprisingly enough, asthma is associated with a high mortality rate.

 

The mortality rate of hospitalized patients due to asthma exacerbation is nearly 1/3, and the expenses spent by patients that require emergency treatment or hospitalization due to asthma exacerbation account for more than 80% of the total asthma-related cost, representing a high burden of social cost.

 

Eosinophilic inflammations are found in 50% of all asthma patients and may lead to reduced lung function or asthma exacerbations.

 

In particular, eosinophilic asthma patients that show increased blood eosinophil levels despite appropriate ICS therapy are inadequately controlled with existing treatment therapy including ICS and LABA therapy.

 

Therefore, the quality of life of these patients is threatened by the pain caused by the symptoms and the frequent exacerbation of the disease.

 

Meanwhile, AstraZeneca sought to expand its indication to uncontrolled Fasenra to chronic rhinosinusitis with nasal polyp (CRSwNP), but FDA turned down the final approval and requested additional data.