Fasenra granted approval in EU for hard-to-treat EGPA patients
Add-on therapy OK'd for adults with rare type of ANCA-associated vasculitis
Fasenra (benralizumab) has been granted approval in the European Union as an add-on treatment for adults with relapsing or treatment-resistant eosinophilic granulomatosis with polyangiitis, or EGPA, a rare type of ANCA-associated vasculitis (AAV).
The clearance of Fasenra, “with its convenient, single-monthly injection is a positive step forward for patients with EGPA” in the EU, Ruud Dobber, PhD, executive vice president of the biopharmaceuticals business unit at AstraZeneca, the therapy’s developer, said in a company press release. Dobber added that AstraZeneca “[remains] committed to helping patients with some of the hardest-to-treat diseases.”
The sole other approved therapy for EGPA, Nucala (mepolizumab), is also administered once a month, but via three under-the-skin, or subcutaneous, injections. The lesser injection requirement for Fasenra is expected to help ease the treatment burden for EGPA patients.
This new approval decision, by the European Commission, follows the therapy’s clearance in the U.S. last month for all adults with EGPA. It also comes about a month after a committee of the European Medicines Agency recommended the approval of Fasenra for EGPA.
In the European Union, the U.S., and several other countries, Fansera already was approved as an add-on treatment for severe eosinophilic asthma. This condition, like EGPA, is marked by excessive numbers of eosinophils, immune cells that normally protect the body against threats, but are also associated with allergic diseases such as asthma.
“Fasenra has been a well-established treatment for many years in thousands of people with severe eosinophilic asthma and we are pleased to now offer a much-needed treatment option for those living with EGPA in Europe,” Dobber said.
Fasenra approval for EGPA in EU based on MANDARA trial data
AAV is a group of autoimmune conditions characterized by inflammation and damage to small blood vessels. EGPA is a rare type of the disease that’s marked by high eosinophils counts. A significant proportion of EGPA patients develop severe eosinophilic asthma.
“People living with EGPA suffer debilitating symptoms, organ damage and even death,” said Bernhard Hellmich, MD, chair of the University of Tübingen’s Teaching Hospital and codirector of the Vasculitis Center Tübingen-Kirchhei, both in Germany. Hellmich serves as principal investigator of MANDARA, an ongoing Phase 3 clinical trial (NCT04157348) that’s testing the therapy in 140 people with EGPA.
According to Hellmich, the therapy’s “approval provides an important treatment option for people living with EGPA in the EU.”
Fasenra is an antibody-based treatment that prevents activation of the interleukin-5 receptor alpha, a protein that’s present at high levels at the surface of eosinophils and essential for these cells’ growth and survival.
The therapy is expected to promote eosinophil death and reduce eosinophil-mediated inflammation, consequently driving and maintaining EGPA remission.
By directly targeting and removing eosinophilic inflammation with [Fasenra], I hope that we will see more patients achieve remission as well as a reduction in the reliance on oral corticosteroids, which can cause serious and long-term side effects.
Fasenra is given as a single 30 mg subcutaneous injection once every four weeks, while Nucala, the other EGPA-approved therapy, involves three separate 100 mg subcutaneous injections every four weeks.
The approvals of Fasenra for EGPA were based on results from MANDARA, which demonstrated that the therapy was at least not inferior to Nucala at promoting disease remission in adults with hard-to-treat EGPA.
In that trial, nearly 60% of participants given Fansera in addition to standard treatment achieved disease remission, and 41% were able to stop standard oral glucocorticoids. The number of patients stopping glucocorticoids was about 1.5 times greater than was seen with Nucala.
“By directly targeting and removing eosinophilic inflammation with [Fasenra], I hope that we will see more patients achieve remission as well as a reduction in the reliance on oral corticosteroids, which can cause serious and long-term side effects,” Hellmich said.
Fansera’s safety and tolerability in MANDARA were consistent with its known profile in other patient populations.
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