“Regarding NASH, we are thrilled with the results of the topline readout we announced last month from our landmark REGENERATE study in patients with fibrosis due to NASH,” Durso continued. “In addition to reinforcing the efficacy of OCA as an antifibrotic, with this second analysis, we now have the benefit of a deeper understanding of safety over a longer period of time. We had a constructive pre-submission meeting with FDA in July, and we look forward to resubmitting our NDA by the end of the year. Given the data we have gathered, we are confident in the improved benefit:risk profile of OCA and its potential role as the first therapy in NASH.”
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