AstraZeneca’s (AZ) Fasenra (benralizumab) has been approved by the US Food and Drug Administration (FDA) to treat adults with eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated inflammatory disease affecting approximately 15,000 people in the US.
Formerly known as Churg-Strauss syndrome, EGPA can result in damage to multiple organs, including the lungs, upper airway, skin, heart, gastrointestinal tract and nerves.
Patients are often treated with chronic high-dose oral corticosteroids (OCS), but can experience recurrent relapses when they attempt to stop taking them.
The FDA’s decision was supported by positive results from the late-stage MANDARA study, in which almost 60% of patients with relapsing or refractory EGPA randomised to receive a single 30mg subcutaneous injection of Fasenra every four weeks achieved remission comparable to patients treated with three separate 100mg subcutaneous doses of mepolizumab, the only approved EGPA treatment, every four weeks.
Data from the trial also showed that 41% of those receiving Fasenra were able to fully taper off oral corticosteroids, compared to 26% in the mepolizumab arm.
International coordinating investigator of the MANDARA trial, Michael Wechsler, the Asthma Institute at National Jewish Health, said: “This approval is great news for patients with EGPA in the US who continue to suffer from debilitating symptoms… [Fasenra] is a much-needed treatment option, with data showing that not only is remission an achievable goal for EGPA patients, but [Fasenra] can also help patients taper off steroid therapy.”
Fasenra is designed to reduce the survival of eosinophils and basophils by interfering with interleukin-5 receptor binding.
The drug was first approved by the FDA in 2017 as an add-on maintenance treatment for severe eosinophilic asthma in patients aged 12 and older, and was approved by the regulator earlier this year for use in severe asthma patients aged six to 11 years with an eosinophilic phenotype.
Ruud Dobber, executive vice president, biopharmaceuticals business unit, AZ said: “Fasenra is already well established for the treatment of severe eosinophilic asthma, and with this approval, physicians in the US will now be able to offer an important new, convenient single monthly subcutaneous injection to their patients with EGPA.
“[This] news demonstrates the potential of Fasenra to help patients suffering from eosinophilic diseases beyond severe asthma.”
