Pharma major AstraZeneca on Tuesday announced that its asthma drug Fasenra failed to meet one of two main goals of a late-stage study assessing the treatment’s benefits in a chronic allergic condition.
The condition, eosinophilic esophagitis, is characterised by inflammation and damage to the esophagus and typically requires repeated treatments, such as corticosteroids and diet change, to ease the symptoms.
“High-level results from the MESSINA Phase III trial showed that AstraZeneca’s Fasenra (benralizumab) did not meet one of the two dual-primary endpoints. Fasenra demonstrated a statistically significant improvement in histological disease remission, but not a change in dysphagia symptoms, compared to placebo, in patients with EoE aged 12 years or older,” the company said in a statement on Tuesday.
Earlier this year, Sanofi and partner Regeneron’s Dupixent became the first treatment to target underlying causes of the disease after it gained U.S. approval.
“The results from the MESSINA Phase III trial in eosinophilic esophagitis confirm that Fasenra achieved near complete depletion of tissue eosinophils, consistent with its mechanism of action, however this did not translate into an improvement in dysphagia symptoms. We will continue to analyse the complete data set to share with the scientific community,” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca said in a statement on Tuesday.
Despite the setback from the trial, AstraZeneca announced that it would continue to analyse the complete data set, which included 210 patients, and present its results at a future medical meeting.
According to a report by news agency Reuters, it could be difficult for AstraZeneca to file for wider approvals of its drug with no patient benefit.
Last year, Fasenra reported sales of $1.26 billion and is approved as an add-on maintenance treatment in severe eosinophilic asthma in the U.S., Europe and Japan and some other countries.
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