ONO 7643 (anamorelin HCI) filed with EU for unintended weight loss in non-small cell lung cancer- Helsinn

The European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) for ONO 7643 (anamorelin HCI), from Helsinn, a novel, orally active selective ghrelin receptor agonist under development for the treatment of anorexia, cachexia, or unintended weight loss in non-small cell lung cancer (NSCLC) patients.

ONO 7643 significantly increased lean body mass (LBM) compared with placebo in two Phase III trials comprising the largest trial program of its kind to date in Non-Small Cell Lung Cancer (NSCLC) patients with Cachexia, an area of significant unmet medical need. In both pivotal 12-week studies, ROMANA 1 and ROMANA 2, anamorelin was shown to significantly increase lean body mass compared with placebo. In ROMANA 1, the median change in LBM was 1.10 kg for anamorelin compared with -0.44 kg for placebo. In ROMANA 2, the median change in LBM was 0.75 kg for anamorelin compared with -0.96 kg for placebo.