Fasenra approval for EGPA in EU recommended by committee
CHMP issues positive opinion on therapy's use for hard-to-treat adults
A European Medicines Agency (EMA) committee has issued a positive opinion recommending the approval of Fasenra (benralizumab) as an add-on treatment for adults with hard-to-treat eosinophilic granulomatosis with polyangiitis (EGPA).
If approved for the recommended indication, the AstraZeneca therapy would be a new option for patients in the European Union who experience relapses or do not respond to standard treatment, including the use of oral glucocorticoids — medications whose long-term use is linked to serious side effects.
“With [this] recommendation, the EGPA community in Europe is one step closer to accessing a new and convenient treatment option to alleviate some of the impact of this debilitating disease,” Ruud Dobber, PhD, executive vice president of the biopharmaceuticals business unit at AstraZeneca, said in a company press release.
The positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) follows Fasenra’s recent U.S. approval for the treatment of adults with EGPA, a rare form of ANCA-associated vasculitis (AAV).
Fasenra approval in Europe would give patients new treatment option
In several countries, among them nations in Europe and North America, Fasenra already is available as an add-on treatment for severe eosinophilic asthma, a form of asthma characterized by high levels of immune cells called eosinophils — a hallmark shared with EGPA.
“People living with EGPA in Europe often face debilitating symptoms and suffer serious and long-lasting side effects from treatment with long-term oral corticosteroids,” said Bernhard Hellmich, MD, a principal investigator of the global MANDARA clinical trial (NCT04157348) whose data supported the recommendation. That ongoing trial Phase 3 trial is expected to be completed in 2026.
“With its unique mechanism of action that leads to near complete depletion of eosinophils, Fasenra represents a much-needed potential treatment option for EGPA patients to help them achieve remission and taper off steroid therapy,” added Hellmich, also the codirector of the Vasculitis Center Tübingen-Kirchhei in Germany.
AAV comprises a group of autoimmune conditions marked by inflammation and damage to small blood vessels. EGPA is a rare form of the disease that is also characterized by high levels of eosinophils, which are involved not only in the fight against invaders but also in allergy and asthma-associated inflammation.
Administered through under-the-skin, or subcutaneous, injections, Fasenra works by preventing the activation of IL-5 receptor alpha, a protein highly present at the surface of eosinophils. The protein’s activation is essential for these cells’ growth and survival.
The therapy is expected to promote eosinophil death and lessen eosinophil-mediated inflammation, thereby driving and maintaining EGPA remission while lowering the need for standard glucocorticoids.
With its unique mechanism of action that leads to near complete depletion of eosinophils, Fasenra represents a much-needed potential treatment option for EGPA patients to help them achieve remission and taper off steroid therapy.
The MANDARA trial evaluated Fasenra’s safety and efficacy against Nucala (mepolizumab), a previously approved therapy for EGPA, in 140 adults with difficult-to-treat disease. Both Fasenra and Nucala work to promote the death of eosinophils.
Participants were randomly assigned to receive either a single Fasenra injection (at a dose of 30 mg) or three Nucala subcutaneous injections (at a dose of 100 mg) every four weeks for about a year, in addition to standard treatment.
The trial’s main goal was to show Fasenra was at least not inferior to Nucala at promoting disease remission. Data showed that rates of disease remission were similar between the Fasenra and Nucala groups (59% vs. 57%).
In addition, twice as many patients on Fasenra were able to stop oral glucocorticoids in the last month of treatment (41% vs. 26%).
Fasenra’s safety and tolerability profile was consistent with its known profile, with headache and sore throat being the most common side effects.
“With over 15 years of clinical data, Fasenra is a well-established, leading treatment for severe eosinophilic asthma, and now has the potential to transform care for patients with EGPA,” Dobber said.
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