FDA postpones the review and decision date of the first potential Nash drug of intercept

Recently, intercept pharmaceuticals announced that the U.S FDA delayed the review and decision date of its potential first Nash new drug, obacholic acid (OCA) For NASH, which has not yet come out of innovative therapy, it is a good thing As a powerful specific farnesol X receptor (FXR) agonist, obecholate has previously achieved positive results in a phase 3 clinical trial called regenerate The results showed that at 18 months of treatment, the improvement of liver fibrosis was more than 1 grade in patients receiving intention to treat (ITT) with different doses of OCA, and the proportion of patients without deterioration of Nash symptoms was 17.6% (10 mg) and 23.1% (25 mg), compared with 11.9% in placebo group This is also the only Nash therapy under development that has achieved positive results in the later stage of clinical trials Based on the results of this trial, intercept submitted a new drug listing application to the U.S FDA Last November, the FDA accepted the listing application and granted it priority review qualification According to the original plan, FDA should reply before March 26 this year In December, however, the FDA informed intercept that it would hold an advisory committee meeting on April 22 to discuss the drug's data Given that this date is later than March 26, intercept expects a delay in the FDA response date On January 15, the FDA informed the company that it would postpone the decision to June 26, a full three months later than the original date Intercept's announcement also points out that this indicates that FDA needs more time to review data and complete the review In an interview with biopharma dive on January 15, Dr mark pruzanski, CEO of intercept, remained optimistic: "I am very confident We are ready, and we will promote the successful launch of this new drug " We are still looking forward to the final approval of this treatment, which will bring good news to patients around the world! reference material: [1] CURRENT REPORT, Retrieved January 17, 2020, from http://ir.interceptpharma.com/static-files/ab5d8681-1a31-4025-9f26-addcd3ff37ae [2] While expected, Intercept's approval delay adds to NASH uncertainty, Retrieved January 17, 2020, from https:// The original title of express delivery? Nash's first potential new drug will be delayed for 3 months A kind of