AstraZeneca focuses on improving competitiveness of NMOSD

'Soliris' is covered by insurance reimbursement starting in April

'Ultomiris' has been approved by the U.S. FDA for an additional indication

(From upper left) Soliris, Ultomiris.

AstraZeneca focuses on improving the competitiveness of neuromyelitis optica spectrum disorder (NMOSD) treatments.

 

The company aims to target the market as its new blockbuster drugs, 'Soliris (eculizumab),' which is used to treat paroxysmal nocturnal hemoglobinuria (PNH), and 'Ultomiris (ravulizumab),' which is a treatment for neuromyelitis optica spectrum disorder (NMOSD), expand indications.

 

In 2021, Soliris received approval for an expanded indication for NMOSD in South Korea.

 

After a prolonged discussion about its listing for insurance reimbursement, Soliris can now be reimbursed for insurance under expanded criteria starting this month (April).

 

The specifics of reimbursement criteria include adult NMOSD patients aged 18 and above who test positive for anti-aquaporin-4 (AQP-4) antibodies, with at least two symptom relapses within the past year or at least three relapses within the past two years (including at least one relapse in the past year).

 

Soliris can be prescribed when 'Mabther (Rituximab)' or ' Enspryng (satralizumab)' treatment cannot be continued due to relapses or side effects following administration.

 

In terms of Ultomiris, after a failed attempt last September, it secured U.S.

 

FDA approval for an additional indication last month.

 

Ultomiris has a higher adherence rate than Soliris.

 

While Soliris requires injections every two weeks, Ultomiris is administered every eight weeks, resulting in longer intervals between doses.

 

The expansion of Ultomiris indications is based on the global Phase 3 CHAMPION-NMOSD study results.

 

During the 73-week treatment period (median value), none of the patients who received Ultomiris relapsed, resulting in a reported 98.6% reduction in relapse risk compared to the control group.

 

On average, NMOSD is a chronic autoimmune disorder that affects the central nervous system.

 

It is estimated to impact approximately 200,000 people worldwide and is more commonly found in women aged 30 to 40.

 

Initially recognized as a variant of multiple sclerosis, a chronic inflammatory demyelinating disease of the central nervous system, NMOSD was distinguished from multiple sclerosis upon the discovery of disease-specific antibodies (aquaporin-4 [AQP4]-IgG) in opticospinal myelitis patients' serum.

 

According to the Korean Society of Neuroimmunology, as of 2017, about 3.56 individuals per 100,000 are estimated to be affected by NMOSD.

 

It is estimated that there are over 1,000 NMOSD patients in South Korea.

 

The average onset age of NMOSD in South Korea is reported to be 43 years old, with a prevalence that is 4.7 times higher in females than in males.