AstraZeneca’s Fasenra (benralizumab) has been approved by the European Commission (EC) to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated inflammatory disease that affects approximately 118,000 people globally.
The drug has been specifically authorised by the regulator for use as an add-on treatment for adults with relapsing or refractory disease.
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, but can experience recurrent relapses when they attempt to stop taking them.
Fasenra, which is already approved in the EU as an add-on maintenance treatment for severe eosinophilic asthma, is designed to reduce the survival of eosinophils and basophils by interfering with interleukin-5 receptor binding.
The EC’s latest decision on the drug follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the late-stage MANDARA study, in which patients were randomised to receive either a single 30mg subcutaneous injection of Fasenra, or three separate 100mg subcutaneous injections of mepolizumab every four weeks.
Almost 60% of Fasenra-treated patients achieved remission, which was comparable to those receiving mepolizumab, and 41% of those being treated with Fasenra were able to fully taper off oral corticosteroids, compared to 26% in the mepolizumab arm.
Ruud Dobber, executive vice president, biopharmaceuticals business unit, AZ, said: “[This] approval of Fasenra, with its convenient, single-monthly injection is a positive step forward for patients with EGPA.
“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.”
The new authorisation comes less than two months after Fasenra received approval from the US Food and Drug Administration to treat adults with EGPA.
The US regulator also approved the drug earlier this year for use in severe eosinophilic asthma patients aged six to 11 years with an eosinophilic phenotype.
