White House Reviews FDA Finalists; Wainua Heart Drug Fails
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- The White House is reviewing a shortlist of FDA commissioner candidates that includes White House adviser Heidi Overton, oncologist and health system executive Jeffrey Vacirca, and Defense Department health affairs official Stephen Ferrara.
- Kyle Diamantas has been serving as acting FDA commissioner since Marty Makary resigned earlier this year.
- AstraZeneca and Ionis saw their stocks tumble after Wainua, their closely watched heart failure drug, failed in a pivotal trial.
- Wainua was a core part of AstraZeneca's strategy to reach $80 billion in annual sales, making the trial failure a significant blow to the company's growth targets.
- Analysts partly attributed Wainua's trial failure to recent FDA approvals of competing ATTR-cardiomyopathy drugs from Alnylam and BridgeBio, which had already placed many patients on alternative therapies.
Why it matters: The White House's FDA commissioner search coincides with AstraZeneca and Ionis's Wainua failing a pivotal trial, sending both companies' stocks down. AstraZeneca's stated $80 billion annual sales target relied in part on Wainua, and rival ATTR-cardiomyopathy drugs from Alnylam and BridgeBio have already enrolled many patients.
