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news.The FDA has granted fast track status to an HIV drug being co-developed by Vertex Pharmaceuticals and GlaxoSmithKline. GSK plans to initiate a mid-phase study of the drug in HIV infected patients in the third quarter of 2005.
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The fast track designation has been awarded to the drug as it is intended for the treatment of a serious or life-threatening condition, and demonstrates the potential to address an unmet medical need for the condition. It means that the companies will receive developmental support from the FDA, and the FDA may expedite the regulatory review process.
The designation is based on the positive results from earlier studies of the drug, which is currently known as VX-385.
“This designation recognizes the clinical and non-clinical results for 640385, which support the potential to address the needs of patients with resistant HIV strains,” said Dr Joshua Boger, chairman, president and CEO of Vertex.