Brinavess is used for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults, for non-surgery patients with AF of seven days or less and for post-cardiac surgery patients with AF of three days or less.
Brinavess approval has resulted from the outcomes of three randomised, double-blind, placebo controlled studies (ACT I, ACT II, and ACT III) and an active comparator trial (AVRO).
Merck Cardiovascular Franchise senior vice president and general manager Patrick Magri said that they welcome this milestone in their collaboration with Cardiome and look forward to launching Brinavess in the EU beginning in the fourth quarter of 2010.
In 2009, Cardiome and Merck had entered into a collaboration and license agreement for the development and commercialization of vernakalant.
The agreement provides Merck, Sharp and Dohme Corp (MSD, formerly known as Merck & Co Inc) with exclusive global rights to vernakalant oral formulation for the maintenance of normal heart rhythm in patients with AF.
The agreement also provides another Merck affiliate, Merck Sharp & Dohme (Switzerland) GmbH, with exclusive rights outside of the US, Canada and Mexico to vernakalant IV formulation for rapid conversion of recent onset AF to sinus rhythm in adults.
Source: Pharmaceutical Bussiness Review
