BRIEF—Soliris approved in China for NMOSD

Soliris (eculizumab), one of UK pharma major AstraZeneca’s top selling drugs, has been approved in China for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+).

Soliris is the first and only complement inhibitor approved for the treatment of NMOSD in China, the company noted.

The approval by the National Medical Products Administration (NMPA) in China was based on results from the Phase III PREVENT trial.

AstraZeneca established a rare disease business unit in China in September 2021.

In June this year, Soliris gained China approval for the treatment of adult patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive..

In the future, the company aims to continue introducing more innovative medicines in China, targeting the complement system and beyond, for the treatment of rare diseases, including PNH, aHUS, gMG, NMOSD, hypophosphatasia, immunoglobulin A nephropathy, lupus nephritis and amyloidosis.