BioCentury
ARTICLE | Clinical News

CHMP recommends against Helsinn's Adlumiz

May 26, 2017 7:39 PM UTC

EMA’s CHMP recommended against approval of an MAA from Helsinn Healthcare S.A. (Lugano, Switzerland) for Adlumiz anamorelin (ONO-7643) to treat anorexia, cachexia or unintended weight loss in non-small cell lung cancer (NSCLC) patients.

CHMP said their decision was based on concerns that the product showed only a “marginal effect” on lean body mass and “no proven effect on hand grip strength or patients' quality of life.” CHMP also said inadequately recorded safety data for Adlumiz contributed to the recommendation...