AstraZeneca's Saphnelo (Anifrolumab) Set to Become First I-Type Interferon Receptor Antibody Approved in EU for Systemic Lupus Erythematosus in Over a Decade

December 21, 2021 /BioValleyBIOON/ --AstraZenecaAstraZeneca recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval.Saphnelo (anifrolumab): As an add-on therapy for the treatment of moderate to severe active autoantibody-positive systemic conditions in patients receiving standard therapy.Systemic Lupus Erythematosus(SLE) Adult PatientsNow, the CHMP opinion will be submitted to the European Commission (EC) for review, which typically makes a final decision within 2 months. If approved, Saphnelo will become the first new treatment for SLE in Europe in over a decade.

In August 2021, Saphnelo was approved by the U.S. FDA, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy. Notably, this approval of Saphnelo,MarksThe regulatory authority's first approval of a Type I interferon (Type I IFN) receptor antagonist, which is also the first in the U.S. in the past 10 years.FDAThe first new therapy approved for SLE.

SLE is the most common type of lupus, affecting up to 300,000 people in the United States. The disease is complexAutoimmunityDisease can affect any organ, and patients often experience inadequate disease control, long-term organ damage, and a poor health-related quality of life. In March 2011,GlaxoSmithKlineBenlysta (Chinese trade name: 倍力腾, generic name: belimumab) received approval in the United StatesFDAApproved, becoming the first treatment for SLE in nearly 60 years after hydroxychloroquine was approved in 1955.

The active pharmaceutical ingredient in Saphnelo is anifrolumab, a fully human monoclonal antibody that binds to the type I interferon receptor subunit 1, blocking the activity of all type I interferons, including IFNα, IFNβ, and IFN-ω. Type I interferons are cytokines involved in inflammatory pathways. Elevated type I interferon gene signatures, which have been shown to correlate with disease activity, are present in 60%-80% of adult patients with systemic lupus erythematosus (SLE). Clinical data indicate that by targeting the type I interferon receptor, Saphnelo treatment significantly reduces disease activity in SLE patients.

United StatesFDAThe approvals and the positive opinion from the EU CHMP are based on efficacy and safety data from the Saphnelo clinical development program, including two TULIP Phase 3 trials and one MUSE Phase 2 trial. The results of the TULIP-2 trial were published in January 2020 in the New England Journal of Medicine, the results of the TULIP-1 trial were published in December 2019 in The Lancet Rheumatology, and the results of the MUSE trial were published in November 2016 in Arthritis & Rheumatology.

In these trials, patients all received standard treatment,Compared with the placebo group, a higher proportion of patients in the Saphnelo treatment group experienced a reduction in disease activity across entire organ systems, including skin and joints, and achieved a sustained reduction in oral corticosteroid (OCS) use.. In these three itemsClinical TrialIn China, patients receiving Saphnelo treatment more frequently experiencedAdverse ReactionsIncluding rhinitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, and cough.

The treatment goal of SLE is to reduce disease activity, prevent damage to organs caused by the disease itself or medications, especially corticosteroids, in order to improve quality of life. Saphnelo will offer the lupus community an effective new treatment option that significantly improves overall disease activity while reducing the use of corticosteroids. This groundbreaking medication has the potential to meaningfully improve the lives of patients with SLE.

Currently, the Phase 3 trial for the subcutaneous formulation of Saphnelo in treating SLE has been initiated. AstraZeneca also plans to conduct multiple Phase 3 studies to evaluate Saphnelo in treating lupus nephritis and cutaneous conditions.Systemic Lupus ErythematosusAnd myositis.

SLE is a chronicAutoimmuneSexually transmitted diseases, where the immune system attacks the body's healthy tissues, can lead to a series of symptoms if not controlled, including pain, rashes, fatigue, joint swelling, fever, long-term organ damage, and even premature death. The disease also has a significant impact on the patient's physical and mental health. It is estimated that there are approximately 5 million lupus patients worldwide, and traditional treatments include steroids and immunosuppressants.

In 2011,GSKBenlysta (Belimumab), Approved in the U.S. and EU for Treating Autoantibody-Positive SLE Adult Patients, Becomes the First New SLE Treatment in Nearly 60 Years. In December 2020 and May 2021, Benlysta was approved in the U.S. and EU for treating Lupus Nephritis (LN). With the approval of this new LN indication, Benlysta has become the first and only biologic therapy approved for treating both SLE and LN.

Saphnelo and Benlysta have different mechanisms of action. The latter is the first specific inhibitor of B lymphocyte stimulator (BLyS), which can block the binding of soluble BLyS (a B cell survival factor) to the BLyS receptor on B cells. Benlysta does not directly bind to B cells, but by binding to BLyS, it inhibits the survival of B cells (including autoreactive B cells) and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Benlysta can reduce the number of abnormal B lymphocytes that exacerbate the condition of lupus patients. These abnormal B lymphocytes cause the immune system to erroneously attack blood vessels and other healthy tissues in the body, leading to lupus and other immune system disorders.

In China, Benlysta (trade name: Belimumab) was approved for marketing by the NMPA in July 2019.As the world's first biologic agent approved for the treatment of SLE, Benlysta has now been approved in China for use in combination with conventional therapy. It is suitable for adult patients with active, autoantibody-positive SLE who still exhibit high disease activity despite standard treatment. Belimumab is a fully human monoclonal antibody administered intravenously, inhibiting B-cell proliferation and differentiation while inducing the apoptosis of autoreactive B cells.Apoptosis, thereby reducing autoantibodies in the serum and achieving the purpose of treating SLE.

It is worth mentioning that,In March 2021, Rongchang Biopharmaceutical announced: the world's first treatment for systemicSystemic Lupus ErythematosusThe "dual-target" novel biologic drug for SLE — Tai'ai (generic name: Telitacicept) has received marketing approval from the National Medical Products Administration, and it is also the first domestically produced dual-target Class I new drug approved for marketing in China in 60 years.

The uniqueness of Telitacimab lies in its ability to simultaneously target two key cytokines, BLyS and APRIL. Studies have found that BLyS and APRIL are crucial factors for the abnormal maturation and differentiation of B cells, and the levels of BLyS and APRIL in patients with SLE determine the severity of the disease. By inhibiting BLyS and APRIL, the signaling pathway of abnormal B cells can be completely suppressed, effectively reducing the body's...AutoimmuneResponse, achieving the purpose of treating SLE. (Bioon.com)

Source of the original text:Saphnelo recommended for approval in the EU by CHMP for the treatment of patients with systemic lupus erythematosus