European Medicines Agency accepts to review Helsinn’s MAA for anamorelin HCI

Anamorelin HCI is a novel, orally active selective ghrelin receptor agonist being developed to treat anorexia, cachexia, or unintended weight loss in NSCLC patients.

Helsinn said ghrelin is an endogenous peptide primarily secreted by the stomach. After binding to its receptor, ghrelin stimulates various pathways in the positive regulation of body weight, lean body mass, appetite and metabolism.

Anamorelin, which is currently under investigations, has not yet been approved by any other global regulatory authority.

Helsinn Group CEO Riccardo Braglia 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."

In 2013, Helsinn granted Chugai Pharma Marketing exclusive commercialization rights to anamorelin for three major European pharma markets.

Helsinn retained all development activities (CMC, preclinical and clinical) and supply of anamorelin for commercial use.

Helsinn will be responsible for the regulatory and clinical development whilst Chugai Pharma Marketing will undertake all the commercial actions within Germany, France, Benelux, the UK and Ireland.