Detailed FDA reviews for BLA 125469 concluded that the clinical data provided "sufficient data to support approval". Key findings from the regulatory process included:
: While initially approved for adults, supplemental reviews (like sBLA 125469/S-051) have assessed its use in pediatric patients aged 10–17 years. 125469
While the pharmaceutical review is the most prominent, the number may also refer to: CDTL Review and Division Summary Memo for Regulatory Action Detailed FDA reviews for BLA 125469 concluded that
: The drug was not referred to an advisory committee because its safety profile was similar to other approved drugs in its class and didn't raise unexpected issues. 125469