- Cardiome Pharma Corp.'s stock tumbled on Monday after the company revealed data supporting a new approval filing for its heart medication weren't strong enough to gain favor with the Food and Drug Administration.
- U.S. regulators determined the data package for Cardiome's Brinavess, which includes safety results from preclinical investigations conducted at the FDA's request and other post-marketing studies, wouldn't be sufficient for a resubmitted New Drug Application, according to an Aug. 21 statement from the drugmaker.
- Brinavess, formerly known as Kynapid, is a corrective treatment for arrhythmic heartbeat that has already gained approved in roughly 50 countries. Cardiome hasn't been able to push the drug into the stateside market, however, despite more than a decade of trying.
The FDA's latest position dampens what has otherwise been a successful year of commercialization efforts for Cardiome. The Vancouver, Canada-based drugmaker locked down authorization to begin marketing Brinavess (vernakalant hydrocholoride) in its home country in June as well as its antibiotic Xydalba (dalbavancin) in France in early March.
And the company's stock reflected those wins — from early January to close of market on Aug. 20 shares were up about 36% to $3.85 apiece.
Shares plummeted more than 22% Monday, though, as a resubmission for Brinavess remains elusive.
"We are disappointed that the Agency did not find these data compelling enough to recommend a resubmission, especially when several regulatory bodies in major jurisdictions around the world, including Canada in March 2017, have found the drug to be safe and effective," Cardiome's CEO William Hunter said in an Aug. 21 statement.
Cardiome's frustration is understandable given the struggles it has had trying to get Brinavess through the U.S. regulatory pathway.
The drug was first filed for approval in 2006, back when Astellas Pharma U.S. Inc. was partnering on its development and commercialization. The FDA immediately hit Astellas with a refuse-to-file letter, citing issues with the database that backed up vernakalant hydrocholoride's filing. Two years later, the agency found the drug approveable, but then determined more clinical work was needed before it could really get the go-ahead.
Cardiome and Astellas subsequently initiated a Phase 3 study dubbed ACT 5 to show their drug's safety and efficacy. The trial was soon suspended, though, after one patient demonstrated a serious adverse event, cardiogenic shock. By 2011, Astellas had sold off its rights to Brinavess to Merck & Co.
Regulators outside the U.S. have approved Brinavess as a treatment for rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults who hadn't received cardiac surgery and have atrial fibrillation that lasts for less than seven days or who had cardiac surgery and have atrial fibrillation that lasts less than three days.
According to the FDA, roughly three million people in the U.S. have AF. Of the condition's many dangers, blood clots are particularly concerning for healthcare providers. As such, the FDA has approved newer blood thinners such as Pradaxa (dabigatran), Xarelto (rivaroxaban) and Eliquis (apixaban) in recent years to bring more effective treatments than warfarin to market.