Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.

Despite its legal stay of execution, lack of confirmatory data means the European Commission’s decision for market removal is likely to stand.

The FXR agonist drug is facing market removal in the EU and possibly the US, which could open the door for two new PPAR agonist therapies.