(Alliance News) - AstraZeneca PLC on Monday said the EU's Committee for Medicinal Products for Human Use of the European Medicine Agency recommended the approval of ultomiris for the treatment of adult patients with a form of neuromyelitis optica spectrum disorder.
The Cambridge, England-based pharmaceutical company said the recommended approval is for adults with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 antibody positive.
NMOSD is a rare autoimmune disorder of the central nervous system. In the disease, healthy cells are attacked by the immune system disrupting messages from the brain and spinal cord to the rest of the body, causing weakness, worsened vision or other symptoms. People who are anti-aquaporin-4 antibody positive have severe optic neuritis with poor vision.
Marc Dunoyer, Chief Executive Officer of AstraZeneca's Alexion, which is focused on rare diseases, said: "Today's positive opinion advances our commitment to transform outcomes for patients with rare neurological diseases and reflects the exceptional efficacy of C5 inhibition in reducing the risk of life-altering relapses in NMOSD.
"For patients with AQP4 Ab+ NMOSD, Ultomiris, the first and only long-acting C5 complement inhibitor, 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 as we work to make Ultomiris available to people living with NMOSD in the EU and around the world." C5 is a protein which is involved in inflammatory and cell killing processes.
AstraZeneca shares were up 0.2% to 11,252.00 pence each in London on Monday morning.
By Tom Budszus, Alliance News reporter
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