RedHill Biopharma views regulatory pathway for RHB-101 in CHF and hypertension

Emerging Israeli biopharma company RedHill Biopharma (TASE: RDHL) says that it recently concluded a positive Type B meeting with the US Food and Drug Administration regarding its cardio drug RHB-101, a controlled release, proprietary, once-daily formulation of carvedilol, for the treatment of congestive heart failure and hypertension.

Following the positive FDA meeting, the company plans to submit a New Drug Application seeking marketing approval of RHB-101 in the USA. Based on the FDA’s feedback, prior to the NDA submission, the company plans to conduct additional chemistry, manufacturing and controls (CMC) work and to conduct a comparative bioavailability study and a dose linearity study.

The planned single dose comparative bioavailability study versus Coreg CR (the branded controlled release carvedilol marketed by GlaxoSmithKline in the USA) is intended to assess the comparability of RHB-101 pharmacokinetics to Coreg CR and follows the prior successful completion of four pharmacokinetic (PK) clinical trials comparing RHB-101 to Eucardic (the branded immediate release carvedilol marketed by Roche in Europe, equivalent to Coreg).