Should the treatment have been approved, it would have become only the second to reach patients specifically created to combat the condition, after GSK’s Benlysta (belimumab).
However, in Phase III trials AstraZeneca’s anifrolumab, a monoclonal antibody (mAb), was unable to hit its primary endpoint of statistically-significant reduction in disease activity in patients with moderate-to-severe systemic lupus erythematosus (SLE).
Lupus is an autoimmune disease wherein the immune system attacks various parts of the body, including the joints, skin and brain.
The outcome of the trial will come as a blow to AstraZeneca, as GlobalData predicted that the drug could become a market leader in the area and achieve annual sales of $144.9m (€124.4m) by 2025.
With GSK having the only treatment targeted for the condition, it announced last year that it would need to spend $139m to expand capacity at its Maryland, US site.
At the time, AstraZeneca cited growing demand for the drug and the expectation that FDA approval for subcutaneous formulation could see this increase – an approval it subsequently received.
AstraZeneca stated that it would reveal the full results of the trial at a future medical meeting.
AZ’s push into biologics
Despite this setback, AstraZeneca has spent the last few years expanding its biologic manufacturing network and penning partnership deals in the area.
Just last month, it announced a partnership with 4D Molecular Therapeutics to develop a gene therapy for chronic lung disease – an area where the company has also looked at developing a mAb treatment.
The company told us several years ago that its pipeline was now developing a greater focus on biologics.