With the FDA’s approval, Fasenra will compete with GSK’s Nucala, which in December 2017 became the first biologic approved for eosinophilic granulomatosis with polyangiitis.
The FDA on Wednesday signed off on the expansion of AstraZeneca’s Fasenra (benralizumab) for the treatment of rare autoimmune condition eosinophilic granulomatosis with polyangiitis.
According to the pharma, the approval was supported by data from the Phase III MANDARA trial, which pit Fasenra against GSK’s Nucala (mepolizumab), previously the only approved therapy for eosinophilic granulomatosis with polyangiitis (EGPA). Patients with refractory or relapsing disease were given either 30 mg of Fasenra or 300 mg of Nucala monthly for 52 weeks.
Results showed that Fasenra could match GSK’s biologic, eliciting a 59% remission rate versus 56% in the Nucala arm. The difference of 3 percentage points did not meet the statistical bar for superiority but was enough to establish the non-inferiority of Fasenra. Duration of remission was also comparable between groups.
More patients in the Fasenra group were able to completely taper off of oral corticosteroid treatment, with 41% qualifying for withdrawal versus 26% in the Nucala group. Fasenra’s safety in MANDARA was consistent with its known profile.
Ruud Dobber, executive vice president of AstraZeneca’s biopharma business unit, in a statement said Wednesday’s approval “demonstrates the potential of Fasenra to help patients suffering from eosinophilic disease beyond severe asthma” and will allow doctors in the U.S. “to offer an important new, convenient single monthly subcutaneous injection” to EGPA patients.
Afflicting 15,000 patients in the U.S., EGPA is a rare and autoimmune condition characterized by the inflammation of small to medium blood vessels. Patients with this disease often experience weight loss, muscle and joint pain, rashes, extreme fatigue and shortness of breath, among other symptoms. In its more severe forms, EGPA can damage several organs across the body including the heart, gastrointestinal tract and lungs. If left unchecked, the condition can prove deadly.
Patients are usually treated using high-dose oral corticosteroids, but tapering these down can lead to relapses. Before Fasenra’s approval, the only biologic for EGPA was GSK’s Nucala, which was approved for this indication in December 2017. According to AstraZeneca, around half of patients fail to reach remission with current treatments.
Fasenra is a humanized IgG1 monoclonal antibody that targets the IL-5 receptor, plays an important role in the inflammatory cascade. The FDA first signed off on the biologic in November 2017 for severe eosinophilic asthma in patients aged 12 years and older. Recently, AstraZeneca secured a crucial expansion to Fasenra’s label for the treatment of younger children aged six to 11 years.
