Janssen R&D files TMC 435 to the FDA for Hepatitis C
Janssen R&D has submitted a New Drug Application (NDA) to the FDA seeking approval for TMC 435 (simeprevir) 150mg capsule with pegylated interferon and ribavirin for the treatment of genotype 1 chronic Hepatitis C in adult patients. The submission is supported in part by data from three pivotal Phase III studies: QUEST-1 and QUEST-2 in treatment-na�ve patients and PROMISE in patients who have relapsed after prior interferon-based treatment.
In each study, participants were treated with one 150 mg simeprevir capsule once daily for 12 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks. Primary efficacy data from the Phase III studies will be presented at an upcoming medical meeting.
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