AstraZeneca Receives U.S. FDA Approval for Self-Administration of SAPHNELO in Lupus Treatment

Saphnelo is approved in the U.S. for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus. 

The approval by the FDA for subcutaneous administration of anifrolumab (SAPHNELO) granted treatment of people living with moderately to severely active autoantibody-positive systemic lupus erythematosus (SLE). It showed that subcutaneous (SC) administration of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe SLE while receiving standard therapy.  

The intravenous (IV) administration of SAPHNELO IV infusion was approved for moderate to severe SLE in 2021. Consistent with the known clinical profile of SAPHNELO, administered as an intravenous (IV) infusion, leads to a safety profile. 

According to Towards Healthcare, the autoinjectors market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 4.42 billion in 2026 to approximately USD 12.05 billion by 2035, representing a compound annual growth rate (CAGR) of 11.8% from 2026 to 2035. Growth is driven by the rise in the prevalence of conditions such as diabetes, rheumatoid arthritis, and multiple sclerosis, which are significantly impacting the market. Innovations in autoinjectors, such as smart technology and needle-free systems, are enhancing user experience and treatment outcomes.  

Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, Ruud Dobber, said since its launch, SAPHNELO IV infusion 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. 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. 

About SAPHNELO 

SAPHNELO IV is the first biologic with remission data in SLE from a four-year placebo-controlled Phase III trial (TULIP-LTE) measured with the DORIS criteria for remission. It can increase the risk of serious infections, including respiratory infections and shingles. It is important to avoid initiating treatment during an active infection and to consider the individual benefit-risk if using in patients with severe or chronic infections. 

It works by blocking the activity of type I interferons, which are proteins that can contribute to the overactive immune response seen in lupus. By inhibiting these signals, Saphnelo helps reduce inflammation and improve symptoms associated with SLE. 

A recent report by Towards Healthcare highlights that the autoinjectors market is witnessing growth driven by the increasing prevalence of chronic and autoimmune diseases, the need for self-administered medications, and favourable reimbursement policies. The market is also experiencing steady growth due to the rising prevalence of diabetes and anaphylaxis, as well as the increasing incidence of allergic reactions.