FDA’s 2008 approval of Valeant Pharmaceuticals International Inc./Lundbeck Inc. ’s Xenazine (tetrabenazine) – still the only drug currently cleared in the U.S. for Huntington’s disease – illustrates the agency’s flexibility on efficacy endpoints in the space.
There could be some lessons learned for Prana Biotechnology Ltd. ’s PBT2, which succeeded in demonstrating a statistically significant...