Wedoany.com Report-Dec.22, AstraZeneca PLC announced on December 16 that the European Union has approved a subcutaneous self-administration formulation of Saphnelo (anifrolumab) for adult patients with moderate to severe systemic lupus erythematosus (SLE) when used alongside standard therapy.

The approval follows a positive recommendation from the Committee for Medicinal Products for Human Use and is supported by results from the Phase III TULIP-SC trial. In the study, patients receiving Saphnelo with standard treatment experienced a significant reduction in disease activity compared to those given placebo with standard treatment.

This development provides a more convenient administration option for patients managing SLE, an autoimmune disease affecting over 3.4 million people worldwide. In Europe, individuals with SLE face a mortality risk two to three times higher than the general population.

Saphnelo works by targeting the type I interferon pathway, which plays a key role in SLE inflammation. The new subcutaneous delivery allows patients to self-administer the treatment at home using a pre-filled syringe or autoinjector, potentially improving adherence and quality of life.

Market analysts have responded positively to AstraZeneca's progress. On December 10, Rajesh Kumar from HSBC maintained a Buy rating on the company's shares and increased the price target from $95 to $108. The day before, on December 9, Steve Scala from TD Cowen also reaffirmed a Buy rating with a $105 price target.

Rajesh Kumar expressed continued confidence in AstraZeneca, noting that the pharmaceutical sector is positioned for strong performance in 2026. Steve Scala highlighted the company's promising new medicines and robust development pipeline as primary factors supporting the favorable outlook.

AstraZeneca operates as a global biopharmaceutical firm focused on discovering, developing, producing, and distributing prescription medicines. The company serves both primary care physicians and specialists across various therapeutic areas.

This EU approval expands patient access to Saphnelo, which was previously available only through intravenous infusion. It represents another step in AstraZeneca's efforts to address unmet needs in autoimmune diseases and strengthen its immunology portfolio.

The subcutaneous formulation is expected to launch in European markets in the coming months, subject to local reimbursement processes. AstraZeneca continues to advance additional research into treatments for SLE and related conditions to further support affected patients.