Former FDA oncology reviewer Paz Vellanki, MD, PhD, of Precision for Medicine, discusses how CDER's ARC program supports novel end points such as ctDNA for rare diseases and why sponsors should engage FDA early.
|Articles|August 6, 2013
Convergence Pharmaceuticals Receives Orphan-Drug Designation for Nav1.7 Blocking Pain Drug CNV1014802
Author(s)Melanie Sena
Designation granted by FDA for the treatment of trigeminal neuralgia.
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‘802 is a small molecule that penetrates the central nervous system and blocks Navs in a highly state-dependent fashion, while exhibiting selectivity against the 1.7 subtype. The drug is currently in a Phase II trial.
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