Roche Korea’s new NMOSD treatment Enspryng is approved

Improved treatment convenience with self-administration every four weeks

Targets IL-6 receptor activity… demonstrated efficacy in reducing risk of relapse

Roche’s neuromyelitis optica spectrum disorder (NMOSD) treatment ‘Enspryng’ was approved in Korea.

 

On the 25th, Roche Korea announced that the Ministry of Food and Drug Safety (MFDS) approved Enspryng (satralizumab) for the treatment of adults with aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), NMOSD is a rare autoimmune disorder of the central nervous system that primarily damages the optic nerve and spinal cord, causing loss of vision and neurological damage.

 

Although its clinical characteristics are similar to multiple sclerosis, over half of the patients with NMOSD experience severe loss of vision and gait disturbance to the extent that the patient becomes wheelchair-bound within 5 to 10 years.

 

In particular, 80-90% of the patients experience frequent relapses.

 

As even a single relapse could cause permanent disability, preventing relapses through maintenance therapy is a key goal in the treatment of NMOSD.

 

Enspryng has an innovative mechanism of action that selectively inhibits interleukin-6 (IL-6) receptor activity, which plays a key role in the inflammation associated with NMOSD.

 

The novel recycling antibody technology applied to Enspryng allows for a longer duration of antibody circulation and a longer IL-6 inhibition effect.

 

Also, the new drug has improved dosing convenience allowing the patient or his/her caregiver to inject Enspryng subcutaneously every four weeks at home as maintenance therapy.

 

The MFDS approval is based on the results of the two Phase III clinical studies ▲ SAkuraSky and ▲SAkuraStar.

 

In the studies, Enspryng demonstrated its clinical efficacy in preventing and reducing the risk of relapse in patients with all states of AQP4-IgG seropositive NMOSD.

 

Among AQP4-IgG seropositive patients, over 9 out of 10 patients who were treated with Enspryng and immunosuppressant combination therapy, and over 7 out of 10 patients treated with monotherapy remained relapse-free for approximately 2 years (96 weeks).

 

SAkuraSky, the pivotal Phase III study that evaluated the efficacy and safety of Enspryng in combination with immunosuppressive therapy enrolled 83 patients with NMOSD aged 12 to 74.

 

Results showed that 89% and 78% of patients on Enspryng combination therapy were relapse-free at weeks 48 and 96, achieving a 62% reduction in the risk of relapse compared to patients on placebo (placebo-immunosuppressant therapy combination).

 

In particular, the study showed that 92% of the AQP4-IgG seropositive patients, the patient group approved for the use of Enspryng, remained relapse-free at weeks 48 and 96, and Enspryng reduced the risk of recurrence by 79% compared to placebo.

 

SAkuraStar, the pivotal Phase III study evaluating the efficacy and safety of Enspryng monotherapy, enrolled 95 patients with NMOSD aged 18 to 74.

 

Results showed that 76% and 72% of patients treated with Enspryng remained relapse-free at weeks 48 and 96, and reduced the risk of relapse by 55% compared to the placebo group.

 

83% of the patients with AQP4-IgG seropositive NMOSD who were treated with Enspryng remained relapse-free at week 48, and 77% at week 96, reducing the risk of relapse by 74% compared to the placebo group.

 

Enspryng was approved by Health Canada (HC) and Japan’s Ministry of Health, Labour and Welfare (MHLW) in June last year.

 

The drug also received approval from the US Food and Drug Administration in August of the same year.