Complete Response Letters
Disc Medicine, Inc.: bitopertin
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Feb 13, 2026
With respect to the first factor, we agree that Trial 201, one adequate and well controlled trial, demonstrated an effect on its primary endpoint.
CRL_NDA220707_20260213:p1:s32Confirmatory evidence was provided from a second, randomized, open-label rial, Trial 202, in which bitopertin 60 mg was superior to bitopertin 20 mg for the primary biomarker endpoint of percent change from baseline to Day 169 of whole blood metalree PPIX in adult and adolescent patients with EPP or XLP (p=0.018).
CRL_NDA220707_20260213:p1:s35More Complete Response Letters
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