European Commission

Ultomiris approved in EU for adults with AQP4-positive NMOSD

Ultomiris (ravulizumab) has been approved by the European Commission to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who test positive for antibodies against aquaporin-4 (AQP4). “Effective NMOSD management hinges on reducing relapses – even a single relapse may cause irreversible disabilities leaving patients unable to move, speak…

Uplizna Approved in Europe for NMOSD Adults With Certain Antibodies

The European Commission has approved Uplizna (inebilizumab-cdon) to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who test positive for antibodies against aquaporin-4 (AQP4-IgG). The approval covers all member states in the European Union, as well as Iceland, Liechtenstein, and Norway. Horizon Therapeutics, the company marketing Uplizna,…

Europe Awaits Proposed New Framework for Sharing Health Data

The European Commission is expected to propose a new governing framework for health data next month, called the European Health Data Space (EHDS), with the aim of connecting national health systems to facilitate secure and efficient transfer of data across systems in different European nations. The move is expected to…

Enspryng Approved for NMOSD in European Union

The European Commission has approved Enspryng (satralizumab) for the treatment of people, 12 and older, with neuromyelitis optica spectrum disorder (NMOSD) who are positive for antibodies against the aquaporin-4 protein (AQP4-IgG). The approval covers Enspryng for use as a monotherapy (on its own) or in combination with other…