Fasenra, developed by AstraZeneca, has received EU approval as an add-on treatment for adults with relapsed or refractory EGPA. This new indication is based on the results of the Phase III MANDARA clinical trial, which showed that 60% of patients achieved remission and 41% were able to discontinue oral corticosteroids.
Promising results from the MANDARA trial
The MANDARA trial, published in The New England Journal of Medicine, was the first to directly compare two biologics for EGPA. Participating patients received either one 30 mg injection of Fasenra or three 100 mg injections of mepolizumab every four weeks. Results showed that both treatments achieved comparable remission rates, highlighting the added benefit of Fasenra in allowing a higher percentage of patients to stop taking corticosteroids, which are known for their long-term side effects.
An expected treatment option
According to Dr. Bernhard Hellmich, principal investigator of the MANDARA trial, the approval of Fasenra represents an important treatment option for people with EGPA, who experience debilitating symptoms and are at risk for damage to multiple organs. “By directly targeting eosinophilic inflammation, we hope to see more remissions and less dependence on corticosteroids,” Hellmich said.
Ruud Dobber, Executive Vice President of AstraZeneca’s Biopharmaceuticals business unit, said that this approval reaffirms the company’s commitment to helping patients with difficult-to-treat diseases. “The convenient, single-monthly injection of Fasenra is a positive step forward for these patients in Europe, following years of good results in people with severe eosinophilic asthma,” he said.
Eosinophilic granulomatosis with polyangiitis: a disease of high medical need
EGPA is a rare and severe form of vasculitis that affects small and medium-sized blood vessels, causing inflammation and possible damage to the lungs, heart and nerves. Without treatment, it can be fatal and affects around 118,000 people worldwide. Symptoms include extreme fatigue, joint pain and shortness of breath. Until now, treatment options were limited and patients relied heavily on high-dose corticosteroids, which exposes them to long-term risks.
Fasenra's safety and expansion profile
Fasenra’s safety profile in the MANDARA trial was consistent with previous studies and other approved uses of the medicine. Fasenra is also currently in development for diseases such as chronic obstructive pulmonary disease and hypereosinophilic syndrome, reinforcing AstraZeneca’s commitment to developing innovative treatments in the respiratory and immunological areas.
With this approval, Fasenra becomes the second biologic drug approved in Europe for EGPA, adding a valuable resource in the treatment of this complex disease.
