AstraZeneca has received a positive recommendation from the Committee for Medicinal Products for Human Use for the subcutaneous self-administration of Saphnelo (anifrolumab) for adults with systemic lupus erythematosus on top of standard therapy. The opinion moves the therapy closer to offering people with SLE a once-weekly, at-home treatment option in the European Union.

The recommendation is based on interim findings from the Phase 3 Tulip-SC trial. The study showed that subcutaneous dosing of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared with placebo in people with moderate to severe, autoantibody-positive SLE who were already receiving standard therapy. The safety profile was consistent with the intravenous formulation, which is already authorised.

Thomas Dörner, rheumatologist and investigator of the Tulip-SC trial, said: “The positive recommendation for the subcutaneous administration of anifrolumab in the EU is highly encouraging for people living with systemic lupus erythematosus, as many still rely on oral corticosteroids, which carry significant side effects and are known to accelerate damage and functional impairment. With the latest treatment recommendations for SLE now placing increased importance on the use of biologics and earlier intervention to target remission while minimising steroids, a subcutaneous form of anifrolumab has the potential to offer broader access for patients.”

The Phase 3 study enrolled 367 participants aged 18 to 70 with moderate to severe, active, autoantibody-positive disease. Participants were randomised to receive a 120mg subcutaneous dose of anifrolumab or placebo administered once a week via a pre-filled, single-use syringe. Disease activity was measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment at week 52. A planned interim analysis was conducted when 220 participants reached this time point. An open-label extension is ongoing for those who completed the initial treatment period.

Ruud Dobber, executive vice president of the biopharmaceuticals business unit at AstraZeneca, said: “Saphnelo IV infusion has already helped transform outcomes for many patients with systemic lupus erythematosus. 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. We are also advancing a robust development programme to explore Saphnelo’s potential in other diseases where type 1 interferon plays a central role, including cutaneous lupus erythematosus, lupus nephritis, myositis and systemic sclerosis.”

SLE is a chronic autoimmune disease affecting millions worldwide. It predominantly affects women and can lead to joint symptoms, rashes, fatigue and organ involvement. Mortality remains significantly higher than in the general population. Oral corticosteroids are widely used but do not address underlying disease drivers and their long-term use is associated with irreversible organ damage. Updated European guidance emphasises early treatment aimed at remission or low disease activity and recommends minimising steroid exposure.

The availability of a subcutaneous option may help increase access to biologic treatment, as many people in Europe receiving biologic therapy for SLE already use subcutaneous formulations. Regulatory reviews for this Saphnelo formulation are ongoing in several countries. The intravenous infusion is authorised in more than 70 countries including the US, EU and Japan, and has been used by more than 40,000 people globally.

Saphnelo is a monoclonal antibody targeting the type 1 interferon receptor subunit 1, blocking downstream inflammatory pathways implicated in SLE. AstraZeneca is continuing clinical development in several immune-mediated diseases, including systemic sclerosis, myositis, cutaneous lupus and lupus nephritis.

Tags: Saphnelo, anifrolumab, systemic lupus erythematosus, SLE, Tulip-SC, CHMP, AstraZeneca, subcutaneous biologic, interferon signalling, autoimmune disease, EU drug approval, regulatory affairs, immunology

AstraZeneca’s Saphnelo (anifrolumab) has received a positive opinion from the Committee for Medicinal Products for Human Use for a once-weekly, self-administered subcutaneous option for adults with systemic lupus erythematosus on top of standard therapy.

The recommendation is supported by interim data from the Phase 3 Tulip-SC study, which showed that subcutaneous dosing reduced disease activity compared with placebo in people with moderate to severe, autoantibody-positive disease. The safety profile was consistent with the intravenous formulation, which is already approved in multiple regions.

Thomas Dörner, rheumatologist and investigator on the Tulip-SC study, said: “The positive recommendation for the subcutaneous administration of anifrolumab in the EU is highly encouraging for people living with systemic lupus erythematosus, as many still rely on oral corticosteroids, which carry significant side effects and are known to accelerate damage and functional impairment. With the latest treatment recommendations for SLE now placing increased importance on the use of biologics and earlier intervention to target remission while minimising steroids, a subcutaneous form of anifrolumab has the potential to offer broader access for patients.”

The Tulip-SC interim analysis was conducted once the first 220 of 367 participants reached week 52. The study used the British Isles Lupus Assessment Group based Composite Lupus Assessment to measure disease activity. Participants were randomised to receive either a 120mg subcutaneous dose of anifrolumab or placebo via a pre-filled syringe while continuing standard therapy. An open-label extension will follow for those who complete the treatment period.

Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, AstraZeneca, said: “Saphnelo IV infusion has already helped transform outcomes for many patients with systemic lupus erythematosus. 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. We are also advancing a robust development programme to explore Saphnelo’s potential in other diseases where type 1 interferon plays a central role, including cutaneous lupus erythematosus, lupus nephritis, myositis and systemic sclerosis.”

SLE is a chronic autoimmune condition that affects more than three million people worldwide. Symptoms vary widely and may include joint swelling, rashes, fatigue and fevers. European data show that people with SLE face a higher mortality risk than the general population. Oral corticosteroids remain widely used but do not address underlying drivers of the disease and carry risks related to long-term exposure. Updated clinical guidance in Europe stresses early treatment to reach remission or low disease activity while limiting steroid use.

Around seven in ten people in Europe who receive a biologic for SLE already use a subcutaneous option, and the new formulation of Saphnelo is intended to provide an additional home-use route. AstraZeneca has regulatory submissions underway in several other countries, while the IV formulation is cleared in more than 70 markets including the US, EU and Japan. More than 40,000 patients have been treated globally.

Saphnelo is a monoclonal antibody that binds to subunit 1 of the type 1 interferon receptor, blocking downstream inflammatory pathways associated with SLE. The medicine continues to be investigated in immune-mediated diseases where type 1 interferon is considered a meaningful driver, including cutaneous lupus, systemic sclerosis, myositis and lupus nephritis.