By Michael Susin


AstraZeneca said the U.S. Food and Drug Administration has requested modifications to improve its Ultomiris treatment's risk evaluation and mitigation strategy.

The Anglo-Swedish pharma giant said Wednesday the FDA issued a response letter to a Biologics License Application requesting to enhance the mechanism to further validate patients' meningococcal vaccination status or prophylactic administration of antibiotics prior to treatment.

However, the FDA didn't request additional analysis of the Phase 3 trial data and didn't raise concerns about the efficacy or safety data from the study, AstraZeneca said.

The company said it is working closely with the FDA regarding next steps for the risk evaluation and mitigation strategy modifications.

AstraZeneca's Ultomiris is a treatment for adult patients with neuromyelitis optica spectrum disorder, which is currently approved for the treatment of certain adults in the European Union, Japan and other countries.


Write to Michael Susin at


(END) Dow Jones Newswires

September 06, 2023 02:36 ET (06:36 GMT)

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