Satralizumab: First Approval
- PDF / 836,534 Bytes
- 6 Pages / 595.276 x 790.866 pts Page_size
- 40 Downloads / 144 Views
ADISINSIGHT REPORT
Satralizumab: First Approval Young‑A Heo1
© Springer Nature Switzerland AG 2020
Abstract Satralizumab (Enspryng®), a humanized anti-interleukin-6 (IL-6) receptor monoclonal recycling antibody, has been developed by Chugai Pharmaceutical and Roche for the treatment of neuromyelitis optica spectrum disorder (NMOSD). In June 2020, based on positive results from two pivotal phase III trials, subcutaneous satralizumab received its first global approval in Canada for the treatment of NMOSD in adults and children aged ≥ 12 years who are aquaporin 4 water channel autoantibody (AQP4-IgG) seropositive. Satralizumab was subsequently approved in Japan and Switzerland. Satralizumab is under regulatory review in the EU and USA, and is undergoing clinical development in several countries worldwide. This article summarizes the milestones in the development of satralizumab leading to this first approval for the treatment of NMOSD.
Satralizumab ( Enspryng®): Key points
1 Introduction
A humanized anti-IL-6 receptor monoclonal recycling antibody being developed by Chugai Pharmaceutical and Roche for the treatment of NMOSD
Neuromyelitis optica spectrum disorder (NMOSD) is a rare autoimmune disease of the central nervous system (CNS) that is characterized by inflammatory and demyelinating lesions in optic nerve, spinal cord brainstem and cerebrum, which can lead to progressive impairment of vision and motor functions [1–4]. The primary goal of NMOSD treatment is to reduce the risk of irreversible neurological impairment by preventing relapse and reducing the severity of attacks [5, 6]. Recent research suggested that interleukin-6 (IL-6) has an important role in the immunopathogenesis of NMOSD [1, 2]. IL-6 signalling triggers an inflammatory cascade that is thought to lead to differentiation of T cells into proinflammatory TH17 cells, differentiation of B cells into plasmablasts that produce aquaporin 4 water channel autoantibodies (AQP4-IgG), a diagnostic serum marker that is found in ≈ 80% of patients with NMOSD, and an increase in blood–brain barrier (BBB) permeability, allowing penetration of antibodies and proinflammatory cells into the CNS [2, 7–10]. Satralizumab (Enspryng®), a humanized anti-IL-6 receptor monoclonal antibody designed using recycling antibody technology™, has been developed by Chugai Pharmaceutical and Roche for the treatment of NMOSD [11]. Based on positive results from two pivotal phase III trials, satralizumab received its first global approval under priority review in Canada on 1 June 2020 for the treatment of NMOSD as monotherapy or as combination therapy with immunosuppressant in adults and children aged ≥ 12 years who are AQP4-IgG seropositive [11]. On 29 June 2020, satralizumab
Received its first approval on 1 June 2020 in Canada Approved for use in Canada as a monotherapy or as a combination therapy with immunosuppressant in adults and children aged ≥ 12 years with NMOSD who are AQP4-IgG seropositive
Enhanced material for this AdisInsight Report can be found at https://do
Data Loading...
