An unexpected case of cardiogenic shock forced investigators at Astellas to halt enrollment for a late-stage confirmatory study of the atrial fibrillation drug vernakalant. And while the monitoring committee recommended that the trial go on, the FDA stepped in and demanded to look over all the data before allowing the trial to restart.
Astellas Pharma licensed the North American rights to vernakalant IV from Cardiome, which saw its shares plunge 25 percent in premarket trading.
"Patient safety has been and continues to be the primary concern of both Cardiome and Astellas," said Cardiome CEO Doug Janzen. "We and Astellas will work closely with the clinical trial site, the DSMB and the FDA to review this serious adverse event, and seek to resume patient enrollment and treatment in the ACT 5 study as soon as it is appropriate to do so."
Just last month Cardiome picked up a $30 million milestone from Merck for the EU approval of vernakalant IV. Merck holds the rights to the ex-U.S. market. An oral formulation of vernakalant is also being studied.
- here's the Cardiome release