Nucala Included in China's National Reimbursement Drug List for Treatment of Adults with Eosinophilic Granulomatosis with Polyangiitis

ShanghaiJanuary 18, 2023PR Newswire -- January 18, 2023, GSK announced its biologic Nucala^®(General Name: Mepolizumab Injection) The indication for adult Eosinophilic Granulomatosis with Polyangiitis (hereinafter referred to as EGPA) has been officially included in the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2022)" (hereinafter referred to as the National Medical Insurance Catalog). As the world's first approved targeted human anti-interleukin-5 (IL-5) monoclonal antibody biologic, Mepolizumab was included in the medical insurance in China just one year after its approval in the country. This will effectively improve the accessibility and affordability of this innovative biologic for Chinese EGPA patients, reduce the disease burden on patients, and help enhance the long-term standardized management of the disease.

EGPA is a rare autoimmune disease. Unlike other vasculitis conditions, EGPA predominantly and initially affects the respiratory tract and lungs. However, as the disease progresses, multiple systems in the patient's body can become involved, leading to irreversible organ damage and posing a serious threat to the patient’s life. Elevated levels of peripheral blood eosinophils are one of the main clinical features of EGPA. The current understanding is that the pathogenesis of EGPA involves eosinophil infiltration and anti-neutrophil cytoplasmic antibody-mediated vascular wall damage. Therefore, during treatment, suppressing the levels of eosinophils involved in inflammatory responses is crucial for disease control.

Professor Tian Xinping from the Department of Rheumatology and Immunology at Peking Union Medical College Hospital pointed out: "Currently, some patients with EGPA still face the dilemma of poor disease control and high recurrence rates after treatment with standard regimens, including oral corticosteroids (OCS) and immunosuppressants. Long-term use of steroids and immunosuppressants also tends to cause side effects such as infections, obesity, osteoporosis, diabetes, and hypertension. Therefore, extending the duration of disease remission, reducing relapses, and improving medication safety are crucial for patients. Mepolizumab, as a biologic targeted therapy, can continuously reduce eosinophil levels in EGPA patients to within the normal range, thereby decreasing eosinophil-mediated inflammation and tissue damage and alleviating respiratory and pulmonary symptoms. The inclusion of mepolizumab in the National Reimbursement Drug List (NRDL) will significantly reduce the disease burden on patients and provide further possibilities for long-term disease control and improved quality of life."

The therapeutic target of Mepolizumab is the cytokine IL-5, which is the key cytokine responsible for the maturation, activation, and survival of eosinophils. By binding to IL-5, Mepolizumab blocks its interaction with the surface receptors on eosinophils, inhibits their biological activity, and continuously reduces their numbers to normal levels. This decreases inflammation and tissue damage mediated by eosinophils, helping to maintain a healthy state.

A clinical study (MIRRA study) covering 136 patients (aged 18 years or older) clinically diagnosed with relapsing or refractory EGPA and lasting at least 6 months evaluated the efficacy and safety of 300mg mepolizumab administered every four weeks for 52 weeks, followed by an 8-week follow-up. This study is the first international multicenter, randomized, double-blind, placebo-controlled trial conducted in the EGPA patient population. Results showed that, compared to placebo, the mepolizumab group experienced prolonged remission periods, with a 12-fold increase in long-term remission rates, while the annual relapse rate decreased by 50%. Additionally, the mepolizumab group had lower OCS doses, with 60% of patients reducing their OCS dosage to less than 7.5mg/day.^[1]。 

Vice President and General Manager of GSK China, Qi Xin, stated: "Uniting science, technology, and talent to collectively overcome diseases is GSK's mission. We are committed to enhancing the accessibility and affordability of innovative medicines to help more Chinese patients conquer illnesses. As the world's first monoclonal antibody targeting human anti-interleukin-5 (IL-5), Mepolizumab has progressed from receiving priority review and approval in 2021 to now being included in the medical insurance system. This demonstrates the government’s commitment to reducing the disease burden for patients and supporting innovative drugs. We hope that through joint efforts with the government, clinicians, and all sectors of society, more patients will benefit from this innovative treatment. Moving forward, we will continue to advance clinical research and expand its indications, aiming to provide innovative and precise therapeutic options for more Chinese patients suffering from inflammatory diseases caused by eosinophilia."