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(Alliance News) - AstraZeneca PLC on Monday said its Ultomiris treatment has been approved by the US Food & Drug Administration as the first and only long-acting C5 complement inhibitor to treat neuromyelitis optica spectrum disorder in adults.
The Cambridge-based pharmaceutical company said this was based on positive results from the Champion-NMOSD phase 3 trial, in which Ultomiris met its primary endpoint.
Zero relapses were observed among Ultomiris patients with a median treatment duration of 73 weeks, AstraZeneca explained.
NMOSD is a rare autoimmune disease that affects the central nervous system, including the spine and optic nerves. According to AstraZeneca, over 6,000 adult patients suffer from NMOSD in the US.
Chief Executive Officer Marc Dunoyer said: "We are proud to deliver a transformative, long-acting treatment option that has the potential to eliminate relapses with a convenient dosing schedule every eight weeks. We are grateful to the NMOSD community for their ongoing collaboration and input, which enables us to advance science for rare diseases."
Shares in AstraZeneca were down 0.2% to 10,458.00 pence each in London on Monday morning.
By Sabrina Penty, Alliance News reporter
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