Roche gets FDA approval for NMOSD treatment

Roche announced on Monday that the US Food and Drug Administration (FDA) has approved ‘Enspryng’, ir satralizumab-mwge, as “the first and only” subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).

The Swiss pharmaceuticals giant described NMOSD as a rare, lifelong and debilitating autoimmune disorder of the central nervous system, often misdiagnosed as multiple sclerosis, that primarily damages the optic nerves and spinal cord, causing blindness, muscle weakness and paralysis.

It said Enspryng is a humanised monoclonal antibody, and the only approved therapy designed to target and inhibit interleukin-6 (IL-6) receptor activity, believed to play a key role in the inflammation associated with NMOSD.

The treatment was designed by Chugai, a member of the Roche group, using novel recycling antibody technology, which - when compared to conventional technology - allows for a longer duration of antibody circulation and subcutaneous dosing every four weeks.

“Today’s FDA approval of Enspryng, the first subcutaneous NMOSD treatment using novel recycling antibody technology, builds upon the work we’ve done in multiple sclerosis with ‘Ocrevus’ to develop first-in-class medicines and further the scientific understanding of neuroimmunological diseases,” said Roche’s chief medical officer and head of global product development Levi Garraway.

“We thank the NMOSD community, including patients and investigators who participated in Enspryng clinical trials.”

Roche said Enspryng would be available in the United States in two weeks.