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The EC approved AstraZeneca’s Saphenlo (anifrolumab) for the treatment of active autoantibody-positive systemic lupus erythematosus.
AstraZeneca announced on Feb. 16, 2022 that the European Commission (EC) approved its drug Saphenlo (anifrolumab) as an add-on treatment for adult patients with moderate-to-severe active autoantibody-positive systemic lupus erythematosus (SLE).
According to a company press release, anifrolumab is the first biologic for SLE approved in Europe with an indication that is not restricted to patients with a high degree of disease activity. Approximately 250,000 people in Europe have SLE, mostly consisting of women between the ages of 15 and 45.
“In Europe, there have been limited treatment options for patients living with systemic lupus erythematosus and many patients face poor outcomes,” said Ronald van Vollenhoven, chair of rheumatology and director of the Amsterdam Rheumatology Center in Amsterdam, the Netherlands, in the press release. “Anifrolumab targets the type I interferon pathway, which is known to play a central role in lupus pathophysiology. Today’s approval is an important step forward in treating this disease.”
“[Anifrolumab] is the first new medicine for systemic lupus erythematosus to gain approval in Europe in over a decade and is the only biologic not restricted to patients with a high degree of disease activity,” said Mene Pangalos, executive vice-president, biopharmaceuticals R&D, AstraZeneca, in the press release. “[Anifrolumab] has demonstrated clinically meaningful benefits and we look forward to bringing it to patients as quickly as possible.”