The bile acid sequestrant was designed to be maintained in the stomach over an extended period of time where it was expected to intercept bile before it reached the esophagus.
The approval was based on data from a phase 3 open-label safety study that included a cohort of 6 children 4 months to <6 months of age.
The new formulation does not contain benzalkonium chloride.
The Medicines Health Regulatory Authority confirmed that the AZD1222 trial could proceed after a UK committee concluded its investigations.
Previously, the EUA limited use to patients with severe COVID-19 disease.
Using a blood sample, the test is able to analyze more than 300 cancer-associated genes for alterations.
Currently, there is no available evidence to assess the carcinogenic potential of MNP and CPNP.