April 28, 2026
2 min read
Key takeaways:
- Anifromulab had previously been approved in IV form for systemic lupus erythematosus.
- The decision to approve the Saphnelo Pen was based on results from the TULIP-SC trial.
The FDA has approved a self-administered autoinjector form of anifrolumab for the treatment of systemic lupus erythematosus, according to press release from the manufacturer.
The anifrolumab (Saphnelo, AstraZeneca) autoinjector, dubbed the Saphnelo Pen, has been approved for once-weekly use alongside standard therapy. The drug, a type I interferon receptor antagonist, was first approved in IV form for SLE in 2021.
“The FDA approval of the anifrolumab autoinjector is a monumental step forward in lupus management, literally bringing transformative care right to the patient’s doorstep,” Shivani Garg, MD, PhD, director of the Yale Lupus Clinical Research Program and co-director of the Yale Lupus Program at the Yale School of Medicine, told Healio.
“For years, I have had patients struggling with debilitating SLE and cutaneous lupus erythematosus who would benefit from this targeted therapy, anifrolumab,” she added. “Yet, ultimately, they had to decline anifrolumab simply because they cannot manage the logistical burden of regular IV infusion appointments or afford the cost to cover for infusion appointments. By offering a self-administered option, we are removing a massive barrier to access, giving our patients options, reducing their daily disruptions and putting the power of their treatment directly into their own hands.”
According to the press release, the FDA’s decision was based on data from the phase 3 TULIP-SC trial, published in Arthritis & Rheumatology in January. In that trial, patients with moderate to severe SLE who received subcutaneous anifrolumab alongside standard therapy demonstrated statistically significant and clinically meaningful reductions in disease activity vs. placebo.
In addition, the subcutaneous form’s safety profile was “consistent with the known clinical profile of Saphnelo administered as an IV infusion,” according to the press release.
“The approval of anifrolumab as a self-administered autoinjector is exciting news as it makes this important medicine more convenient and accessible for many more patients,” Susan Manzi, MD, MPH, chair of the Allegheny Health Network (AHN) Medicine Institute, director of the Lupus Center of Excellence at the AHN Autoimmunity Institute, and principal investigator for the TULIP-SC trial, said in the release.
“With its proven ability to significantly reduce disease activity and the risk of organ damage, anifrolumab has been a much-needed innovation in lupus, which is a serious and often debilitating autoimmune condition impacting millions worldwide,” she added.
For more information:
Shivani Garg, MD, PhD, can be reached at shivani.garg@yale.edu.
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