EMA to review Helsinn’s anamorelin HCI marketing authorisation application

The European Medicines Agency (EMA) has accepted for review, the marketing authorisation application (MAA) for Helsinn Group’s anamorelin HCI.

Anamorelin is a noval, 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. 

Helsinn ‘one step closer’ to bringing anamorelin to market

Ghrelin is an endogenous peptide primarily secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, lean body mass, appetite and metabolism. Anamorelin is an investigational agent that has not yet been approved by any regulatory authority. Phase III trials have been designed to assess the tolerability and efficacy of the treatment for increasing body weight, lean body mass and muscle strength.

Commenting on the announcement, Riccardo Braglia, Chief Executive Officer of Helsinn Group, said, “With this EMA submission, we are one step closer to bringing this new and potentially effective treatment to market, meaning that the quality of life for patients with non-small cell lung cancer who suffer from anorexia, cachexia, could soon improve. Anamorelin is part of our pipeline of products dedicated to cancer supportive care, all of which address areas of significant unmet medical need.”