In a business update issued Thursday, Intercept Pharmaceuticals said the April 22 FDA advisory committee meeting for obeticholic acid in liver fibrosis due to non-alcoholic steatohepatitis (NASH) has been tentatively rescheduled to June 9 as a result of the COVID-19 pandemic. The company said "we continue to work closely with the FDA on our priority review application," adding that the decision date for its filing remains June 26, after having been delayed by three months earlier this year.
Meanwhile, the European Medicines Agency is currently reviewing Intercept's application, submitted last December, for obeticholic acid in the same indication. Earlier this month, India became the first country to approve a NASH drug after regulators there cleared Zydus Cadila's saroglitazar to treat patients with non-cirrhotic NASH (for related analysis, see ViewPoints: From the clouds – Zydus Cadila’s saroglitazar wins NASH race).
Intercept also provided an update on how COVID-19 was affecting its clinical development programme, saying it is "monitoring the…situation very closely" and has "taken measures intended to minimise any disruption to our ongoing trials." The company did not give further details except to say that its Phase III NASH studies, REGENERATE and REVERSE, are fully enrolled and that its focus now "is to provide needed support to participating sites and patients around the world."
With respect to Intercept's primary biliary cholangitis (PBC) trials, it stated that "under the current circumstances, we are…temporarily pausing screening and randomisation of patients in certain of our continuing studies of [obeticholic acid] in PBC." The drug is already approved in the US under the name Ocaliva to treat certain patients with PBC, and Intercept said it is working with "third-party manufacturers, distributors and other trusted partners to manage our supply chain activities and mitigate any potential disruptions to our product supplies as a result of COVID-19."
Several drugmakers, including Bristol Myers Squibb, Eli Lilly, Pfizer and others, have issued updates in recent days outlining how they are adjusting their business and clinical activities amid the COVID-19 pandemic, including in some cases by pausing ongoing trials or postponing the start of new ones. For related analysis, see ViewPoints: Impact of COVID-19 on clinical trial enrolment comes into view.
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