New England Journal of Medicine (NEJM) has published the POISE Study (PBC OCA International Study of Efficacy) manuscript in this week’s (W/C 15/08/2016) edition of the journal.
Intercept received FDA approval in the United States at the end of May for obeticholic acid therapy for patients with PBC based mainly upon the results of the POISE study. In Europe, obeticholic acid is an investigational product currently going through the EMA approval process. Intercept, are awaiting their decision and hope to get EMA approval later this year in Europe. Intercept believe that the POISE study and the FDA’s approval represent a large step forward for the benefit of PBC patients and are delighted to have this manuscript published.
If you do not have a subscription of NEJM, and would like a copy of the manuscript and supplement, please email the medical information team at Intercept Pharmaceuticals at firstname.lastname@example.org and they will ensure that an electronic copy is sent to you.