60 Degrees Pharma Plans Tafenoquine Study After FDA Meeting
23 January 2024 - 1:34AM
Dow Jones News
By Chris Wack
60 Degrees Pharmaceuticals said that following a Type C meeting
held Wednesday with the Food and Drug Administration, it will move
forward with a pivotal clinical study of tafenoquine in
hospitalized babesiosis patients in the U.S.
In advance of the meeting, 60 Degrees provided to the FDA an
information package that included a presentation of the unmet
medical need for a new therapeutic for hospitalized babesiosis
patients, as well as a detailed outline of the proposed study
protocol.
The FDA indicated in remarks during the meeting that the
proposed study could be sufficient for regulatory approval,
provided the company uses a clinical endpoint rather than a
surrogate marker.
60 Degrees is now revising its study protocol in light of that
feedback, with the goal of initiating patient enrollment in the
summer of 2024.
Tafenoquine is approved for malaria prophylaxis in patients 18
years and older in the U.S. under the product name Arakoda.
Tafenoquine hasn't been proven to be effective for treatment or
prevention of babesiosis and isn't approved by the FDA for such an
indication.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 22, 2024 09:19 ET (14:19 GMT)
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