Saphnelo now available in Malaysia as an add-on treatment for adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE)

KUALA LUMPUR,Malaysia,July 21,2023 -- AstraZeneca's Saphnelo (anifrolumab) has now become available as add-on treatment for adult patients in Malaysia with moderate to severe,active autoantibody-positive systemic lupus erythematosus (SLE) following insufficient response to standard therapy,after obtaining regulatory approval earlier this year.

SLE is a chronic and complex autoimmune condition that can affect any organ,and patients often experience inadequate disease control,long-term organ damage,and poor health-related quality of life.

The approval was based on positive results from the Saphnelo clinical development programme,including the TULIP Phase III trials.1-2 Across clinical trials,more patients treated with Saphnelo experienced a reduction in overall disease activity across most targeted organ systems and achieved sustained reduction in oral steroid (OCS) use compared to placebo.1-2

Vinod Narayanan,Country President,AstraZeneca Malaysia said: "The approval and availability of Saphnelo in Malaysia represents an important milestone in our ongoing efforts to broaden patients' access to innovative,life-changing medicines and ultimately,improve health outcomes."

"Eligible people living with SLE can now benefit from the treatment of this chronic,complex and often disabling disease," explained Vinod.

Saphnelo targets the type I interferon pathway,which is known to play a central role in SLE pathophysiology.

KKLIU: KKLIU 1721

Tarikh Tamat Tempoh: 7 Disember 2023

References:

1. Morand EF,et al. Efficacy and Safety of Anifrolumab in Patients With Moderate to Severe Systemic Lupus Erythematosus: Results of the Second Phase 3 Randomized Controlled Trial. N Engl J Med. 2020; 382 (3): 211-221.

2. Furie R,et al. Anifrolumab: Type I Interferon Inhibition in Active Systemic Lupus Erythematosus in TULIP-1,a Phase 3,Randomized Controlled Trial. Lancet Rheumatol. 2019; 1 (4): e208-e219.