Antibody drug 'Fasenra' lands in KOR with EGPA indication

In the process of expanding approval criteria of the MFDS

Demonstrated non-equivalence to 'Nucala' based on the Phase 3 trial

Product photo of Fasenra.

Astra Zeneca's Fasenra, an antibody drug for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA), is expected to be introduced in South Korea.

 

According to industry sources on November 29, Astra Zeneca Korea has recently submitted an application to the Ministry of Food and Drug Safety (MFDS) for an expanded indication of Fasenra (benralizumab).

 

The indication is for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) with polyangiitis.

 

Fasenra received the Orphan Drug Designation (ODD) for the EGPA indication in March.

 

It received orphan drug designation from the U.S.

 

Food and Drug Administration (FDA) in 2018.

 

AstraZeneca recently showcased findings from the MANDARA Phase III trial at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

 

This study directly compared Fasenra to GSK's antibody drug, 'Nucala (mepolizumab).' The MANDARA study evaluated the efficacy and safety of Fasenra compared to Nucala in patients with relapsing or refractory EGPA for 52 weeks at 4-week intervals or three monthly Nucala injections.

 

The study included 140 EGPA patients receiving corticosteroid therapy, regardless of immunosuppressant use.

 

The average age of participants was 52 years, and 60% were female.

 

Among the participants, 66% had relapsing disease, and 60% had refractory disease.

 

Study results showed that at 36 and 48 weeks, the remission rates for EGPA were 59% in the Fasenra group and 56% in the Nucala group, showing a slightly increased trend than Fasenra.

 

However, this difference was not statistically significant, and non-inferiority was demonstrated.

 

The secondary endpoints, such as remission duration and time to first relapse, produced comparable outcomes in the Fasenra and Nucala groups.

 

Similarly, average blood eosinophil counts at week 52 were reduced from 306/µL to 32.4/µL in the Fasenra group and from 384.9/µL to 71.8/µL in the Nucala group.

 

Meanwhile, EGPA is a systemic vasculitis associated with asthma, eosinophilia, sinusitis, pulmonary infiltrates, and neuropathy.

 

The disease can cause damage to multiple organs, including the lungs, skin, heart, gastrointestinal tract, and nervous system.

 

This damage accumulates over time and can become fatal if left untreated.

 

Fasenra is a monoclonal antibody that directly binds to the interleukin-5 (IL-5) receptor alpha on eosinophils, inducing rapid and near-complete depletion of blood and tissue eosinophils through programmed cell death in most patients.

 

Currently, Fasenra is approved in multiple countries worldwide as an add-on maintenance therapy for severe eosinophilic asthma and has received approval for self-administration in the United States and Europe.

 

In South Korea, Fasenra was approved by the MFDS in June 2019 for severe eosinophilic asthma.

 

It has recently passed the Drug Reimbursement Evaluation Committee (DREC) review of the Health Insurance Review and Assessment Service (HIRA).