ASTRAZENECA PLC (Alliance News) - AstraZeneca PLC on Wednesday said it is working closely with the US Food & Drug Administration regarding a request to changes to improve risk evaluation for Ultomiris.
The Cambridge-based pharmaceutical company said the FDA requested changes to enhance the risk evaluation & mitigation strategy to further validate patients' meningococcal vaccination status prior to treatment of adults with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 antibody positive.
The company emphasised that the FDA's complete response letter did not request additional reanalysis of phase 3 trial data from Astra's supplemental biologics licence application.
Antibody complement inhibitor Ultomiris in May was approved in Japan for the prevention of relapses in patients with neuromyelitis optica spectrum disorder.
In April last year, the drug was approved in the US for adults with generalised myasthenia gravis - a rare, debilitating, chronic condition that causes muscle weakness. It received approval for the same condition in Japan four months later.
In 2019, Ultomiris was also approved in the US to treat atypical hemolytic uremic syndrome.
AstraZeneca shares were 1.6% lower at 10,560.00 pence each on Wednesday morning in London.
By Tom Budszus, Alliance News reporter
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