Traws Pharma, Inc. announced on May 27, 2025, the receipt of written responses from the U.S. Food and Drug Administration (FDA) following a Type B pre-Investigational New Drug Application meeting for tivoxavir marboxil (TXM). The FDA provided detailed feedback on development paths for potential approval of TXM for bird flu and seasonal flu, including the use of the Animal Rule.
The Animal Rule provides a pathway for approval when human clinical studies are unethical or impractical. Traws Pharma is now requesting a Type D meeting with the FDA to specify the next steps in TXM's development. This regulatory clarity is a crucial step towards bringing TXM to market.
In parallel, the company has initiated dialogue with the Biomedical Advanced Research and Development Authority (BARDA) for inclusion in a national drug stockpiling initiative, recognizing the urgent need for effective countermeasures against bird flu, which has historically been associated with high mortality rates. Traws Pharma also plans to engage with international regulatory agencies for similar stockpiling purposes.
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