AstraZeneca Plc (NASDAQ:AZN) released on Wednesday topline data from RESOLUTE Phase 3 trial of Fasenra (benralizumab).
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Fasenra, despite showing numerical improvement, did not achieve statistical significance in the primary endpoint in patients with chronic obstructive pulmonary disease (COPD), also known as smoker’s lung disease.
The safety and tolerability profile for Fasenra in the trial was consistent with the known profile of the medicine.
The company will analyse the full data set from RESOLUTE.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in more than 80 countries, including the US, Japan, the EU, and China.
It is also approved for SEA in children and adolescents aged six and above in the U.S. and Japan.
Fasenra has also been approved in more than 60 countries for the adult treatment of eosinophilic granulomatosis with polyangiitis, and it is under regulatory review for the treatment of hypereosinophilic syndrome.
AstraZeneca also shared high-level results from a pre-specified interim analysis of the Phase 3 TULIP-SC trial in patients with systemic lupus erythematosus (SLE).
The trial showed the subcutaneous (SC) administration of AstraZeneca's Saphnelo (anifrolumab) demonstrated a statistically significant and clinically meaningful reduction in disease activity compared to placebo.
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The safety profile observed in the interim analysis was consistent with the known clinical profile of Saphnelo administered as an intravenous (IV) infusion.
The reduction in disease activity in TULIP-SC was measured using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at week 52.
The BICLA requires improvement in all organs with disease activity at baseline, with no new flares.
The TULIP-SC interim results are under regulatory review.
Saphnelo IV infusion is approved for moderate to severe SLE in more than 70 countries.
AZN Price Action: AZN stock is up 0.11% at $77.64 at the publication on Wednesday.
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