A company that could become the first to win Food and Drug Administration approval for a drug to treat a form of fatty liver disease has experienced a few months’ delay in the agency reaching its decision. However, analysts sought to assure investors that it did not change their overall upbeat view of the drug.
New York-based Intercept Pharmaceuticals said Friday that the FDA had scheduled an advisory committee meeting to review the drug, obeticholic acid, for treating fibrosis due to nonalcoholic steatohepatitis (NASH), for April 22, 2020. That means the previously announced date for the FDA to decide on whether to approve the drug, March 26, 2020, would be pushed back.
Indeed, the announcement did not appear to affect Intercept’s stock price, with shares rising 5% on the Nasdaq Monday. The company had also hosted a commercial analyst day Monday.
But while a delay in launch for the drug until the second quarter was seen as a mild disappointment, analysts wrote that the high potential for strong physician uptake of the drug after launch was what drove their continued confidence. In a note to investors, Baird analyst Brian Skorney wrote that while a delay is “never ideal,” it remains likely that obeticholic acid will become the first drug approved for NASH.
Following the analyst day, B. Riley FBR analyst Mayank Mamtani wrote that among factors giving confidence was a 64% unaided awareness of the drug among physicians, pointing to a strong prescription trend when it is launched. Moreover, biomarker data indicate more profound efficacy between the 18th and 30th months of therapy than in the first 18-month period from the interim analysis, which bodes well for a readout expected by the end of next year.
Intercept’s announcement stands in contrast with the one from Gilead Sciences, which said Monday that the Phase II ATLAS combination and monotherapy study of firsocostat and cilofexor failed to show a statistically significant increase in the proportion of patients achieving at least a one-stage improvement in fibrosis without worsening of NASH. It nevertheless did show statistically significant improvements in multiple response measures of fibrosis and liver function among patients who received the combination of the two drugs.
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