http://www.medpagetoday.com/clinical-context/PBCNASH/51634
OCA is also in phase 2 trial for PSC…it has been successful in phase3 trial for PBC, so interesting to see how PSC trial goes.
Thanks for this Ted. The outcome of the study is indeed reassuring. Lets hope that PSC patients respond in a similar, if not better way :-)
DO you have any info about the PSC phase 2 trial info?
https://clinicaltrials.gov/ct2/show/NCT02177136
Phase 2 for psc is recruiting patients. Sounds good opportunity to help the community and potentially get the treatment early…
This will take years so FDA approval is not coming any time soon.
Trials should be quicker with the breakthrough and orphan designations.
Phase 2 ends in June 2019…
This has already orphan designation (allows smaller sample size).
I think one of the oca trials actually was completed early because it achieved primary objectives early (it got some breakthough designation for pbc).
Hope same happens in psc trial allowing this to be completed early (very rare).
http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=919926
Intercept Pharmaceuticals Submits Applications in the U.S. and Europe for Marketing Approval of Obeticholic Acid for the Treatment of Primary Biliary Cirrhosis
- First Primary Biliary Cirrhosis Medication Submitted for Regulatory Review in Nearly Two Decades -
This got earlier FDA breakthrough designation since early clinical trial results were so good…hope this works similarly for psc!