We should be highly optimistic; with the acceptance of the NDA, we are on an unchartered course in NASH at the precipice of our first FDA-approved treatment for this liver disease. The implications of this are profound.
Not only do we give hope to our patients with NASH and fibrosis, but we can inform primary care physicians and gastroenterologists that there is an FDA approved treatment for this disease on the horizon. Therefore, the excuse of ‘we aren’t going to look for it because there is no treatment’ is gone.
This will improve disease awareness to patients and to providers. Additionally, it will give hope to the drug development community that there is a pathway to approval if your drug works.
As pharma sees a path to drug approval, they will also see the opportunity to build on the success of Intercept. Hence, it will allow us to move forward with combination therapies to further improve the chances of patients benefiting from obeticholic acid and other drugs to come.
Stephen Harrison, MD
Pinnacle Clinical Research
San Antonio, TX
Disclosures: Harrison reports consulting for Akero, Altimmune, Axcella, Blade Therapeutics, Cirius, CiVi Biopharma, Cymabay, Echosens, Foresite, Galectin, Galmed, Genfit, Genentech, Gilead, Hepion, Hightide, HistoIndex, Innovate, Intercept, Madrigal, Medpace, Metacrine, NGM Bio, Novartis, Novo Nordisk, Perspectum, Poxel, Prometic, Sagimet and Viking.