AstraZeneca (LSE:AZN) announced on Wednesday that its asthma medication Fasenra did not achieve the main objective in a late-stage trial involving patients with chronic obstructive pulmonary disease (COPD).
The company stated that the safety and tolerability observed in the RESOLUTE trial were consistent with the drug’s known profile. It added that a comprehensive review of the trial data will be completed and subsequently shared with the scientific community.
Fasenra is currently approved as an add-on therapy for severe eosinophilic asthma in over 80 countries, including the U.S., EU, Japan, and China. It is also authorized in the U.S. and Japan for children and adolescents aged six and older, and in more than 60 nations for eosinophilic granulomatosis with polyangiitis. Additionally, the treatment is under review for hypereosinophilic syndrome.
The COPD treatment market is attracting growing attention, with Sanofi (EU:SAN) and GSK (LSE:GSK) introducing new therapies, and Merck & Company (NYSE:MRK) moving to acquire Verona Pharma to gain access to a potentially high-revenue treatment. Roche (USOTC:RHHBY) also reported a trial setback in July.
Fasenra has previously struggled in the COPD arena, missing expectations in a 2018 study. In the latest trial, the medication was tested in patients with moderate to very severe forms of the disease.
Separately on Wednesday, AstraZeneca shared positive late-stage results for its lupus therapy Saphnelo. The company stated that the TULIP-SC Phase III study of self-administered Saphnelo met its primary endpoint in patients with systemic lupus erythematosus.
The drugmaker said the results “showed that the subcutaneous (SC) administration of AstraZeneca’s Saphnelo (anifrolumab) demonstrated a statistically significant and clinically meaningful reduction in disease activity compared to placebo.”
The study assessed the safety and efficacy of subcutaneous Saphnelo versus placebo in patients with moderately to severely active, autoantibody-positive lupus, with all participants continuing their standard care.
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