(Sharecast News) - An AstraZeneca treatment for a rare autoimmune disease has been given a potential green light by the European Union, the drugs giant said on Monday.
The treatment, called Ultomirism, has been recommended for marketing authorisation in the EU for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD), an autoimmune disease of the central nervous system, who are AQP4 antibody positive (Ab+).
If authorised, it would be the first and only long-acting complement inhibitor in the EU for AQP4 Ab+ NMOSD.
The recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use was based on positive opinion results from phase III trials.
Marc Dunoyer, chief executive of Alexion, AstraZeneca's specialist rare diseases arm, said: "For patients with AQP4 Ab+ NMOSD, Ultomiris may have the potential to eliminate relapses, while also offering a convenient treatment schedule of infusions every eight weeks.
"We look forward to the European Commission decision."
Astrazeneca (AZN)