Beren, Through its Subsidiary Mandos, Submits New Drug Application to U.S. FDA for Adrabetadex in Infantile-Onset NPC
Beren Therapeutics P.B.C.® (“Beren”) today announced that its subsidiary Mandos LLC® (“Mandos”) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for adrabetadex, an investigational therapy for the treatment of infantile-onset Niemann-Pick disease type C (NPC). The application was based on data supporting a finding of improved survival in an externally controlled survival analysis, biomarker and nonclinical confirmatory evidence, and patient experience narratives.
FDA Grants Breakthrough Therapy Designation to Investigational Drug Adrabetadex for Individuals with Infantile-Onset Niemann-Pick Disease Type C
Beren Therapeutics P.B.C.®, a Public Benefit Corporation and parent company of Mandos LLC®, today announced that Mandos received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for adrabetadex, an investigational drug for infantile-onset Niemann-Pick disease type C (NPC).
