Innovative drug for optic neurospinal corditis spectrum disorder (NMOSD)! Chinese and foreign drug IL-6R single anti-Enspryng approved in Taiwan, China!

December 11, 2020 // -- Chugai recently announced that its antibody drug Enspryng (satralizumab) subsurfic injection has been approved by Taiwan, China, for the treatment of age ≥12 years old, anti-water channel protein-4 (AQP4) antibody-positive optic spinal cord spectrum disorder (NMOSD) adolescents and adult patients.
it is worth mentioning that Enspryng is the first NMOSD drug approved by Taiwan.
NMOSD is a rare, lifelong, debilitating autoimmune disease of the central nervous system that mainly damages the optic nerve and spinal cord, leading to blindness, muscle weakness and paralysis.
In two key Phase III clinical studies, Enspryng, as a monotherapy and as an additional therapy for baseline immunosuppressant therapy (IST), showed strong efficacy in a wide range of NMOSD patient populations and significantly reduced the risk of recurrence.
, Enspryng has also been approved in Japan, Canada, Switzerland, the United States and Australia, and is under review by many regulators, including the European Union.
in Japan, the United States, the European Union, satralizumab have been granted the orphan drug qualification (ODD), and in the United States was also awarded the breakthrough drug qualification (BTD).
NMOSD is usually associated with pathogenic antibodies (anti-AQP4 antibodies), which target and damage a specific cell called astrological glial cells, leading to inflammatory lesions in the optic nerve, spinal cord, and brain.
anti-AQP4 antibodies can be detected in the serum of about 70-80% of NMOSD patients, who tend to experience more severe illnesses.
most cases of NMOSD can be diagnosed through diagnostic testing, up to 30% of patients are often misdiagnosed as multiple sclerosis (MM).
Enspryng is a pH-dependent binding humanized monoclonal antibody that targets interlethytin 6000s (IL-6R), and IL-6R is believed to play a key role in inflammation in NMOSD patients.
the drug was the first product developed by Chugai Pharma using its new antibody recovery technology.
compared to conventional techniques, this technique extends the duration of antibody circulation, maximizes the suppression of IL-6 signals, and minimizes the safety risk in chronic diseases.
patients with NMOSD experience unpredictable and severe relapses, leading directly to cumulative, irreversible nerve damage and disability.
prevention of recurrence through early treatment can have a positive impact on disability prevention, which is the primary goal of NMOSD disease management.
approval by NMOSD (Photo: empr.com), based on positive results from one of the largest critical clinical trial projects for NMOSD.
data from two randomized controlled Phase III studies (SakuraStar, SAkuraSky) confirmed that enspryng was treated as a monotherapy and baseline in adult patients with AQP4 antibody-positive NMOSD Immunosuppressant (IST, commonly used to manage relapse-related NMOSD symptoms) combined treatment has strong and long-lasting efficacy and good safety: Enspryng significantly reduces the risk of recurrence compared to placebos and lasts up to 96 weeks.
- SAkuraStar Study: Assessing the efficacy and safety of Enspryng monotherapy and placebo.
results showed that in the AQP4 antibody-positive subgroup, 76.5 percent of patients in the Enspryng treatment group did not relapse at week 96, and 41.1 percent in the placebo group.
- SAkuraSky Study: Assessed the efficacy and safety of Enspryng Joint Baseline IST and Placebo Joint Baseline IST.
results showed that in the AQP4 antibody-positive subgroup, 91.1% of patients in the Enspryng-IST treatment group did not relapse, and 56.8% in the placebo-IST treatment group.
, the proportion of patients with severe adverse events in the Enspryng treatment group and the placebo group was similar in both studies.
infection rate (including severe infections) in the Enspryng treatment group was lower than in the placebo group.
Most adverse reactions were mild to moderate, and the most common adverse reactions in the Enspryng treatment group ≥15% were nasopharyngitis, headache, upper respiratory tract infection, gastritis, rash, joint pain, limb pain, fatigue and nausea.
data from the two controlled, randomized Phase III clinical trials above show that Enspryng is an effective treatment option, whether used as a single-drug treatment or in association with baseline therapy.
enspryng is injected every four weeks, which is a convenient treatment option for patients and caregivers.
() Original origin: Chugai's Enspryng Approved in Taiwan as First approvedd Medicine for Neuromyelitis Optica Spectrum Disorder (NMOSD)