FDA approves Saphnelo Pen for at-home lupus treatment
Weekly subcutaneous injection designed for use with standard SLE therapy
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The U.S. Food and Drug Administration (FDA) has approved a self-injected version of Saphnelo (anifrolumab-fnia).
Like the original version of Saphnelo, which is given by infusion into the bloodstream every four weeks, the Saphnelo Pen is indicated for use in combination with standard therapy for systemic lupus erythematosus (SLE). But instead of requiring monthly trips to a hospital or infusion center, the new version is given by subcutaneous (under-the-skin) injection once weekly. Patients can inject themselves at home or with support from a healthcare professional or caregiver.
“Since its launch, [the original version of Saphnelo] has helped tens of thousands of people with systemic lupus erythematosus achieve lower disease activity with fewer steroids and has been shown to help many achieve remission,” Ruud Dobber, executive vice president of the biopharmaceuticals business unit at AstraZeneca, which markets Saphnelo, said in a company press release. “The approval of the SAPHNELO Pen represents a significant step forward in expanding SAPHNELO’s clinical benefits to more people living with systemic lupus erythematosus.”
The U.S. approval follows similar approvals in the European Union and Japan. The self-administered therapy, delivered via an autoinjector, is under regulatory review in several other countries, according to AstraZeneca.
New version provides convenience for patients
“The FDA approval of a [Saphnelo Pen] is an exciting milestone for the lupus community because it offers people with systemic lupus erythematosus more convenience and choice of where and how they want to receive treatment,” said Louise Vetter, president and CEO of the Lupus Foundation of America.
Lupus is an autoimmune disease in which the immune system attacks the body’s own healthy tissue. Saphnelo works to dampen this immune attack by blocking the activity of inflammatory signaling molecules called interferons.
The FDA based its approval mainly on data from a Phase 3 clinical trial called TULIP-SC (NCT04877691), which tested the therapy against a placebo in more than 300 people with SLE whose disease wasn’t adequately controlled with standard lupus treatments. The study showed that Saphnelo Pen was superior to the placebo in reducing a range of disease severity measures.
“The approval of [Saphnelo Pen] is exciting news as it makes this important medicine more convenient and accessible for many more patients,” said Susan Manzi, MD, principal investigator of the TULIP-SC trial and chair of the Allegheny Health Network Medicine Institute. “With its proven ability to significantly reduce disease activity and the risk of organ damage, [Saphnelo] has been a much-needed innovation in lupus, which is a serious and often debilitating autoimmune condition impacting millions worldwide.”
