AstraZeneca PLC said its lupus drug Saphnelo succeeded in a late-stage trial for a new, self-injectable formulation, a positive development for the company's drug pipeline.
The Phase III study showed that a subcutaneous, or under-the-skin, version of the drug demonstrated a statistically significant and clinically meaningful reduction in disease activity in patients with systemic lupus erythematosus compared to a placebo, the company said Wednesday.
An intravenous version of Saphnelo is already approved in more than 70 countries, and the new formulation is aimed at providing a more convenient option for patients.
Systemic lupus erythematosus is a chronic autoimmune disease that affects more than 3.4 million people globally and can cause organ damage.
"Today's news takes us one step closer in making the clinically meaningful benefits of Saphnelo accessible for more patients with systemic lupus erythematosus," said Sharon Barr, Executive Vice President, BioPharmaceuticals R&D.
The company said the safety profile of the self-administered version was consistent with the known profile of the infused drug.
The positive results follow recent trial setbacks for the British drugmaker, including failures for an experimental rare-disease drug and a separate treatment for chronic obstructive pulmonary disease.
AstraZeneca said it is working with regulatory authorities to bring the new administration option to patients.
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