60 Degrees Pharma Announces Type C Meeting with FDA to Discuss Development of Tafenoquine for Babesiosis, an Emerging Tick-Borne Disease
Retrieved on:
Wednesday, November 15, 2023
The meeting will take place on January 15, 2024.
Key Points:
- The meeting will take place on January 15, 2024.
- Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA.
- Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such an indication.
- The efficacy and safety of 8-aminoquinolines, a class of drugs that includes tafenoquine and primaquine, for prevention and treatment of malaria is well established.