EMEA Accepts To Review Merck’s MAA For Vernakalant Intravenous

US-based Merck has reported that the European Medicines Agency (EMEA) has accepted to review the company’s Marketing Authorisation Application (MAA), for the regulatory approval of vernakalant intravenous (IV).

Vernakalant is an investigational compound being developed in two formulations, oral and IV, to address multiple unmet needs in the management of atrial fibrillation.

Reportedly, the proposed indication for vernakalant IV is for the treatment of acute atrial fibrillation.

Stefan Oschmann, president at Merck Global Human Health, said: Acute atrial fibrillation represents a significant unmet medical need, particularly for older adults. The decision by EMEA to review vernakalant IV represents an important milestone in our long history of developing novel therapeutics for cardiovascular disease.”