www.fdanews.com/articles/174846-vtesse-rakes-in-breakthrough-therapy-designation-for-vts-270
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Vtesse Rakes in Breakthrough Therapy Designation for VTS-270
January 12, 2016
The FDA has granted breakthrough therapy designation to Vtesse’s VTS-270, thereby offering the company a chance for more guidance and speedier development and review processes.
The cyclodextrin treatment, intended for patients with the rare genetic Niemann-Pick Type C1 Disease, is being tested in a Phase 2b/3 clinical study.
Previously given orphan drug status in both the U.S. and Europe — and with earlier research sponsored by the NIH — VTS-270 is being assessed for its ability to control neurologic symptoms of the fatal disease.