AstraZeneca Says FDA Has Requested Improvements to Ultomiris's Risk Evaluation
06 September 2023 - 8:51AM
Dow Jones News
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 michael.susin@wsj.com
(END) Dow Jones Newswires
September 06, 2023 02:36 ET (06:36 GMT)
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