AstraZeneca's (AZN) Ultomiris Gets FDA Nod for New Indication [Yahoo! Finance]
AstraZeneca PLC - American Depositary Shares (AZN)
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Source: Yahoo! Finance
The approval for long-acting C5 complement inhibitor Ultomiris is for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+). The approval makes Ultomiris the first and the only long-acting C5 complement inhibitor approved for AQP4 Ab+ NMOSD. Patients with NMOSD experience unpredictable relapses, which can involve the onset of new neurological symptoms or the exacerbation of existing ones. These relapses tend to be severe and recurrent, often leading to permanent disability in affected individuals. The approval of Ultomiris for AQP4 Ab+. NMOSD was based on data from the CHAMPION-NMOSD phase III study, which demonstrated that Ultomiris led to unprecedented relapse risk reduction in NMOSD patients. Zero relapses were observed among Ultomiris patients with a median treatment duration of 73 weeks. In September last year, the FDA issued a complete response letter (CRL) to its supplemental biologics
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Sec Filings
- 4/25/24 - Form 6-K
- 4/11/24 - Form 6-K
- 4/11/24 - Form 6-K
- AZN's page on the SEC website