RHB-101 is a once daily controlled release proprietary formulation of Carvedilol. Carvedilol is marketed under various trade names including GSK’s Coreg®. RHB-101 was licensed from Egalet a/s (a private Danish company) in November 2009. As carvedilol, RHB-101 is a β-adrenergic blocking agent with α1-blocking activity and is planned to be indicated for the treatment of heart failure, left ventricular dysfunction (following myocardial infarction) and hypertension. Several clinical PK studies were conducted and RedHill is examining the regulatory path in the US and Europe.
Following a positive Scientific Advice meeting with the Danish Health and Medicines Authority (DKMA) RedHill intends to submit a Marketing Authorization Application (MAA) to market RHB-101 in Europe, with Denmark as the reference member state for the European Mutual Recognition Procedure (MRP).
RedHill is also continuing to explore the parallel regulatory path for marketing approval of RHB-101 in the U.S.