Merck/Cardiome win Euro nod for IV a-fib treatment
An IV form of vernakalant (Brinavess, Merck/Cardiome Pharma) has gained a CE mark for marketing in the European Union, Iceland and Norway. Vernakalant is indicated for the conversion of a recent onset of atrial fribrillation (AF) to sinus rhythm in non-surgery patients with AF of seven days or less and post-cardiac surgery patients with AF of three days or less.
However, the drug is contraindicated in patients with severe aortic stenosis, a systolic blood pressure greater than 100 mmHg and who have HF class III and IV, among other factors.
According to the companies, the vernakalant approval was based on the results of the ACT I, ACT II, ACT III and AVRO trials.
The ACT I and ACT III trials evaluated 390 hemodynamically stable patients with duration of AF from three hours to seven days with placebo. Act I trial results showed that vernakalant converted AF patients to sinus rhythm for a minimum duration of one minute within 90 minutes of initiating therapy in 51 percent of patients; this occurred in 51.2 percent of patients during ACT III.
During the AVRO (Active-Controlled, Multi-Center Study of Vernakalant Injection versus Amiodarone in Subjects with Recent Onset AF) trial, vernakalant proved to be more rapid than amiodarone IV in restoring sinus rhythm in AF patients. Results showed that vernakalant converted 51.7 percent of patients to sinus rhythm at 90 minutes compared with only 5.2 percent with amiodarone, according to the companies.
Back in June, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended marketing approval of vernakalant.
However, the drug is contraindicated in patients with severe aortic stenosis, a systolic blood pressure greater than 100 mmHg and who have HF class III and IV, among other factors.
According to the companies, the vernakalant approval was based on the results of the ACT I, ACT II, ACT III and AVRO trials.
The ACT I and ACT III trials evaluated 390 hemodynamically stable patients with duration of AF from three hours to seven days with placebo. Act I trial results showed that vernakalant converted AF patients to sinus rhythm for a minimum duration of one minute within 90 minutes of initiating therapy in 51 percent of patients; this occurred in 51.2 percent of patients during ACT III.
During the AVRO (Active-Controlled, Multi-Center Study of Vernakalant Injection versus Amiodarone in Subjects with Recent Onset AF) trial, vernakalant proved to be more rapid than amiodarone IV in restoring sinus rhythm in AF patients. Results showed that vernakalant converted 51.7 percent of patients to sinus rhythm at 90 minutes compared with only 5.2 percent with amiodarone, according to the companies.
Back in June, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended marketing approval of vernakalant.