AstraZeneca's Saphnelo nears EU approval for convenient lupus treatment
AstraZeneca's lupus drug Saphnelo has been recommended for approval in the European Union in a new, more convenient self-administered form.
The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion for a once-weekly, under-the-skin injection for adults with systemic lupus erythematosus, or SLE, the company said on Monday.
The recommendation is based on interim results from a late-stage trial which showed the new formulation led to a statistically significant and clinically meaningful reduction in disease activity compared to a placebo.
The safety profile was consistent with the drug's existing intravenous version, which is administered in a clinical setting and is already approved in more than 70 countries.
"With this positive CHMP recommendation, we're one step closer to offering the clinically meaningful benefits of Saphnelo to more people in a convenient, once-weekly self-administration option," said Ruud Dobber, Executive Vice President of AstraZeneca's BioPharmaceuticals Business Unit.
SLE is a chronic autoimmune condition that affects more than 3.4 million people globally.
AstraZeneca said the subcutaneous version of Saphnelo is also under regulatory review in several other countries.
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