Complete Response Letter NDA 505b1 219195 (Nov 27, 2024)
The FDA has identified significant deficiencies in NDA 219195 for govorestat, concluding that the currently available evidence does not support the drug's effectiveness for treating CG, nor does it validate plasma galactitol as a reasonably likely surrogate endpoint for accelerated approval. The agency requires substantial evidence of effectiveness, including new adequate and well-controlled clinical trials, and comprehensive data to support galactitol's role as a surrogate endpoint.
