EU CHMP recommends refusal of application for Adlumiz (anamorelin) for anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer -Helsinn Birex Pharmaceuticals

The EU Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Adlumiz (anamorelin), from Helsinn Birex Pharmaceuticals intended for the treatment of anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer. The company presented results of two main studies involving a total of around 1,000 non-small cell lung cancer patients with cachexia. Patients were given either Adlumiz or placebo (a dummy treatment) and the main measures of effectiveness were changes in lean body mass (body weight excluding fat) and hand grip strength.

The CHMP concluded that the studies show a marginal effect of Adlumiz on lean body mass and no proven effect on hand grip strength or patients’ quality of life. In addition, following an inspection at clinical study sites, CHMP considered that the safety data on the medicine had not been recorded adequately. This meant that a thorough evaluation of potential risks with Adlumiz was not possible. Therefore the CHMP was of the opinion that the benefits of Adlumiz did not outweigh its risks and recommended that it be refused marketing authorisation.