A few days ago, Intercept Pharmaceuticals issued an announcement announcing that the FDA has postponed the review decision date of its potential first NASH new drug, obeticholic acid (OCA). The NASH field, which has been slow to see the emergence of innovative therapies, can be described as good.
As a potent and specific farnesol X receptor (FXR) agonist, obeticholic acid has previously achieved positive results in a phase 3 clinical trial called REGENERATE. The results of the trial showed that within 18 months of treatment, the proportion of patients with intent-to-treat (ITT) who received different doses of OCA improved liver fibrosis by more than Grade 1 and had no deterioration in NASH symptoms at 17.6% (10 mg) And 23.1% (25 mg), this value was 11.9% in the placebo group.
This is currently the only NASH therapy in progress that has achieved positive results in the later clinical trials. Based on the results of this trial, Intercept submitted a new drug marketing application to the US FDA. In November last year, the FDA accepted the listing application and granted it priority review status. According to the original plan, the FDA should respond before March 26 this year.
However, in December last year, the FDA informed Intercept that it would hold an advisory board meeting on April 22 this year to discuss data on the drug. Given that this date is later than March 26, Intercept expects that the FDA response date will also be delayed. On January 15 this year, the FDA actually notified the company that it would postpone the decision date to June 26, which is a full three months behind the original date.
Intercept's announcement also states that this indicates that the FDA needs more time to review the data and complete the review.
On January 15th, Intercept CEO Dr. Mark Pruzanski remained optimistic in an interview with BioPharma Dive: "I am very confident. We are ready and we will promote the successful launch of this new drug." I look forward to the final approval of this therapy, bringing the gospel to patients around the world!