EU Approves Fasenra for Eosinophilic Granulomatosis with Polyangiitis

AstraZeneca has announced that its drug Fasenra (benralizumab) has received approval from the European Union (EU) as an add-on therapy for adult patients suffering from relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). This immune-mediated vasculitis can cause damage to various organs and can be fatal if left untreated.

The European Commission's approval is based on positive results from the MANDARA Phase III trial. The trial's findings, published in The New England Journal of Medicine, indicate that nearly 60% of patients treated with Fasenra achieved remission. Furthermore, 41% of these patients were able to completely stop their oral corticosteroid (OCS) use, compared to 26% in the comparator arm, showing a significant reduction in dependency on OCS.

MANDARA was the first trial to compare biologics head-to-head for treating EGPA. Patients in the trial were randomly assigned to receive either a single 30 mg subcutaneous injection of Fasenra or three separate 100 mg subcutaneous injections of mepolizumab every four weeks. The trial showed that the effectiveness of Fasenra in achieving remission was comparable to that of mepolizumab.

Bernhard Hellmich, the Chair of the Department of Internal Medicine, Rheumatology, and Immunology at Medius Klinik Kirchheim in Germany, expressed optimism about the new treatment option. He highlighted the debilitating symptoms and severe consequences of EGPA, including organ damage and even death. Hellmich believes that targeting eosinophilic inflammation with benralizumab will increase remission rates and reduce reliance on oral corticosteroids, which have serious long-term side effects.

Ruud Dobber, Executive Vice President of AstraZeneca's BioPharmaceuticals Business Unit, emphasized AstraZeneca's commitment to addressing challenging diseases. He pointed out that Fasenra, which has been successfully used to treat severe eosinophilic asthma for years, now offers a new treatment option for EGPA patients in Europe. Dobber praised the drug's convenient single-monthly injection as a significant advancement for managing the disease.

The safety and tolerability of Fasenra in the MANDARA trial were consistent with its known profile. Approximately half of EGPA patients also suffer from adult-onset severe eosinophilic asthma (SEA) and often experience sinus and nasal symptoms. Fasenra is one of only two biologics approved for treating this rare disease.

Fasenra is already approved as an add-on maintenance treatment for SEA in over 80 countries, including the US, Japan, the EU, and China, and it is approved for children and adolescents aged six and above in the US and Japan. Fasenra received approval for EGPA in the US in September.

EGPA, previously known as Churg-Strauss Syndrome, is a rare inflammatory disease caused by inflammation of small to medium-sized blood vessels. It affects around 118,000 people worldwide and can lead to damage in multiple organs, including the lungs, skin, heart, gastrointestinal tract, and nerves. Common symptoms include severe fatigue, weight loss, muscle and joint pain, rashes, nerve pain, and shortness of breath. Without treatment, EGPA can be fatal, and nearly half of the patients do not achieve remission with current treatments, which often involve chronic high-dose OCS use.

The MANDARA trial was a Phase III, randomized, double-blinded, active-controlled study comparing the efficacy and safety of Fasenra to mepolizumab in EGPA patients. The trial involved 140 patients who were randomized to receive either a single 30 mg subcutaneous injection of Fasenra or three 100 mg subcutaneous injections of mepolizumab every four weeks. The primary endpoint was the proportion of patients in remission at weeks 36 and 48, with a secondary endpoint focusing on the proportion of patients who could fully taper off OCS at weeks 48 through 52.

Fasenra is a well-established treatment for severe eosinophilic asthma and is now being developed for other diseases, including chronic obstructive pulmonary disease and hypereosinophilic syndrome. It was developed by AstraZeneca in collaboration with BioWa, Inc., a subsidiary of Kyowa Kirin Co., Ltd., Japan.

AstraZeneca is a global, science-led biopharmaceutical company focusing on the development and commercialization of prescription medicines, particularly in the fields of Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. The company is headquartered in Cambridge, UK, and its innovative medicines are available in over 125 countries, benefiting millions of patients worldwide.