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April 28, 2026<\/p>\n
2 min read<\/p>\n<\/p><\/div>\n
\n \n \n Add topic to email alerts \n <\/span> \n <\/p>\n\n\n \n Receive an email when new articles are posted on \n <\/p>\n\n Please provide your email address to receive an email when new articles are posted on .<\/p><\/div>\n<\/p><\/div>\n “ \n data-action=”subscribe”> \n Subscribe \n <\/button>\n <\/div>\n<\/p><\/div>\n We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong> <\/p>\nBack to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\nKey takeaways:<\/h2>\n\nAnifromulab had previously been approved in IV form for systemic lupus erythematosus.<\/li>\nThe decision to approve the Saphnelo Pen was based on results from the TULIP-SC trial.<\/li>\n<\/ul>\nThe FDA has approved a self-administered autoinjector form of anifrolumab for the treatment of systemic lupus erythematosus, according to press release from the manufacturer.<\/p>\nThe 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.<\/p>\n \n \n \n \n <\/source><\/source><\/source><\/source><\/source><\/picture> \n \n <\/figcaption> \n <\/figure>\n\u201cThe FDA approval of the anifrolumab autoinjector is a monumental step forward in lupus management, literally bringing transformative care right to the patient\u2019s doorstep,\u201d Shivani Garg, MD, PhD,<\/b> director of the Yale Lupus Clinical Research Program and co-director of the Yale Lupus Program at the Yale School of Medicine, told Healio. <\/p>\n\u201cFor years, I have had patients struggling with debilitating SLE and cutaneous lupus erythematosus who would benefit from this targeted therapy, anifrolumab,\u201d she added. \u201cYet, 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.\u201d<\/p>\nAccording to the press release, the FDA\u2019s decision was based on data from the phase 3 TULIP-SC trial, published in Arthritis & Rheumatology<\/i> 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.<\/p>\nIn addition, the subcutaneous form\u2019s safety profile was \u201cconsistent with the known clinical profile of Saphnelo administered as an IV infusion,\u201d according to the press release.<\/p>\n\u201cThe 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,\u201d Susan Manzi, MD, MPH,<\/b> 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. <\/p>\n\u201cWith 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,\u201d she added.<\/p>\nFor more information:<\/h2>\n Shivani Garg, MD, PhD,<\/b> can be reached at shivani.garg@yale.edu. <\/p>\n
\n Receive an email when new articles are posted on \n <\/p>\n\n Please provide your email address to receive an email when new articles are posted on .<\/p><\/div>\n<\/p><\/div>\n “ \n data-action=”subscribe”> \n Subscribe \n <\/button>\n <\/div>\n<\/p><\/div>\n We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong> <\/p>\nBack to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\nKey takeaways:<\/h2>\n\nAnifromulab had previously been approved in IV form for systemic lupus erythematosus.<\/li>\nThe decision to approve the Saphnelo Pen was based on results from the TULIP-SC trial.<\/li>\n<\/ul>\nThe FDA has approved a self-administered autoinjector form of anifrolumab for the treatment of systemic lupus erythematosus, according to press release from the manufacturer.<\/p>\nThe 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.<\/p>\n \n \n \n \n <\/source><\/source><\/source><\/source><\/source><\/picture> \n \n <\/figcaption> \n <\/figure>\n\u201cThe FDA approval of the anifrolumab autoinjector is a monumental step forward in lupus management, literally bringing transformative care right to the patient\u2019s doorstep,\u201d Shivani Garg, MD, PhD,<\/b> director of the Yale Lupus Clinical Research Program and co-director of the Yale Lupus Program at the Yale School of Medicine, told Healio. <\/p>\n\u201cFor years, I have had patients struggling with debilitating SLE and cutaneous lupus erythematosus who would benefit from this targeted therapy, anifrolumab,\u201d she added. \u201cYet, 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.\u201d<\/p>\nAccording to the press release, the FDA\u2019s decision was based on data from the phase 3 TULIP-SC trial, published in Arthritis & Rheumatology<\/i> 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.<\/p>\nIn addition, the subcutaneous form\u2019s safety profile was \u201cconsistent with the known clinical profile of Saphnelo administered as an IV infusion,\u201d according to the press release.<\/p>\n\u201cThe 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,\u201d Susan Manzi, MD, MPH,<\/b> 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. <\/p>\n\u201cWith 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,\u201d she added.<\/p>\nFor more information:<\/h2>\n Shivani Garg, MD, PhD,<\/b> can be reached at shivani.garg@yale.edu. <\/p>\n
“ \n data-action=”subscribe”> \n Subscribe \n <\/button>\n <\/div>\n<\/p><\/div>\n We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong> <\/p>\nBack to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\nKey takeaways:<\/h2>\n\nAnifromulab had previously been approved in IV form for systemic lupus erythematosus.<\/li>\nThe decision to approve the Saphnelo Pen was based on results from the TULIP-SC trial.<\/li>\n<\/ul>\nThe FDA has approved a self-administered autoinjector form of anifrolumab for the treatment of systemic lupus erythematosus, according to press release from the manufacturer.<\/p>\nThe 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.<\/p>\n \n \n \n \n <\/source><\/source><\/source><\/source><\/source><\/picture> \n \n <\/figcaption> \n <\/figure>\n\u201cThe FDA approval of the anifrolumab autoinjector is a monumental step forward in lupus management, literally bringing transformative care right to the patient\u2019s doorstep,\u201d Shivani Garg, MD, PhD,<\/b> director of the Yale Lupus Clinical Research Program and co-director of the Yale Lupus Program at the Yale School of Medicine, told Healio. <\/p>\n\u201cFor years, I have had patients struggling with debilitating SLE and cutaneous lupus erythematosus who would benefit from this targeted therapy, anifrolumab,\u201d she added. \u201cYet, 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.\u201d<\/p>\nAccording to the press release, the FDA\u2019s decision was based on data from the phase 3 TULIP-SC trial, published in Arthritis & Rheumatology<\/i> 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.<\/p>\nIn addition, the subcutaneous form\u2019s safety profile was \u201cconsistent with the known clinical profile of Saphnelo administered as an IV infusion,\u201d according to the press release.<\/p>\n\u201cThe 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,\u201d Susan Manzi, MD, MPH,<\/b> 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. <\/p>\n\u201cWith 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,\u201d she added.<\/p>\nFor more information:<\/h2>\n Shivani Garg, MD, PhD,<\/b> can be reached at shivani.garg@yale.edu. <\/p>\n
Back to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\nKey takeaways:<\/h2>\n\nAnifromulab had previously been approved in IV form for systemic lupus erythematosus.<\/li>\nThe decision to approve the Saphnelo Pen was based on results from the TULIP-SC trial.<\/li>\n<\/ul>\nThe FDA has approved a self-administered autoinjector form of anifrolumab for the treatment of systemic lupus erythematosus, according to press release from the manufacturer.<\/p>\nThe 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.<\/p>\n \n \n \n \n <\/source><\/source><\/source><\/source><\/source><\/picture> \n \n <\/figcaption> \n <\/figure>\n\u201cThe FDA approval of the anifrolumab autoinjector is a monumental step forward in lupus management, literally bringing transformative care right to the patient\u2019s doorstep,\u201d Shivani Garg, MD, PhD,<\/b> director of the Yale Lupus Clinical Research Program and co-director of the Yale Lupus Program at the Yale School of Medicine, told Healio. <\/p>\n\u201cFor years, I have had patients struggling with debilitating SLE and cutaneous lupus erythematosus who would benefit from this targeted therapy, anifrolumab,\u201d she added. \u201cYet, 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.\u201d<\/p>\nAccording to the press release, the FDA\u2019s decision was based on data from the phase 3 TULIP-SC trial, published in Arthritis & Rheumatology<\/i> 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.<\/p>\nIn addition, the subcutaneous form\u2019s safety profile was \u201cconsistent with the known clinical profile of Saphnelo administered as an IV infusion,\u201d according to the press release.<\/p>\n\u201cThe 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,\u201d Susan Manzi, MD, MPH,<\/b> 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. <\/p>\n\u201cWith 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,\u201d she added.<\/p>\nFor more information:<\/h2>\n Shivani Garg, MD, PhD,<\/b> can be reached at shivani.garg@yale.edu. <\/p>\n
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.<\/p>\n
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.<\/p>\n \n \n \n \n <\/source><\/source><\/source><\/source><\/source><\/picture> \n \n <\/figcaption> \n <\/figure>\n\u201cThe FDA approval of the anifrolumab autoinjector is a monumental step forward in lupus management, literally bringing transformative care right to the patient\u2019s doorstep,\u201d Shivani Garg, MD, PhD,<\/b> director of the Yale Lupus Clinical Research Program and co-director of the Yale Lupus Program at the Yale School of Medicine, told Healio. <\/p>\n\u201cFor years, I have had patients struggling with debilitating SLE and cutaneous lupus erythematosus who would benefit from this targeted therapy, anifrolumab,\u201d she added. \u201cYet, 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.\u201d<\/p>\nAccording to the press release, the FDA\u2019s decision was based on data from the phase 3 TULIP-SC trial, published in Arthritis & Rheumatology<\/i> 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.<\/p>\nIn addition, the subcutaneous form\u2019s safety profile was \u201cconsistent with the known clinical profile of Saphnelo administered as an IV infusion,\u201d according to the press release.<\/p>\n\u201cThe 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,\u201d Susan Manzi, MD, MPH,<\/b> 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. <\/p>\n\u201cWith 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,\u201d she added.<\/p>\nFor more information:<\/h2>\n Shivani Garg, MD, PhD,<\/b> can be reached at shivani.garg@yale.edu. <\/p>\n
\u201cThe FDA approval of the anifrolumab autoinjector is a monumental step forward in lupus management, literally bringing transformative care right to the patient\u2019s doorstep,\u201d Shivani Garg, MD, PhD,<\/b> director of the Yale Lupus Clinical Research Program and co-director of the Yale Lupus Program at the Yale School of Medicine, told Healio. <\/p>\n
\u201cFor years, I have had patients struggling with debilitating SLE and cutaneous lupus erythematosus who would benefit from this targeted therapy, anifrolumab,\u201d she added. \u201cYet, 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.\u201d<\/p>\n
According to the press release, the FDA\u2019s decision was based on data from the phase 3 TULIP-SC trial, published in Arthritis & Rheumatology<\/i> 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.<\/p>\n
In addition, the subcutaneous form\u2019s safety profile was \u201cconsistent with the known clinical profile of Saphnelo administered as an IV infusion,\u201d according to the press release.<\/p>\n
\u201cThe 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,\u201d Susan Manzi, MD, MPH,<\/b> 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. <\/p>\n
\u201cWith 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,\u201d she added.<\/p>\n
Shivani Garg, MD, PhD,<\/b> can be reached at shivani.garg@yale.edu. <\/p>\n
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