Three new drug candidates nixed by EMA/CHMP; four biosimilars OKed

20 May 2017

Following the May meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) it was announced that three new marketing authorizations could not be recommended.

The CHMP adopted a negative opinion for Switzerland-based cancer specialist Helsinn Group's Adlumiz (anamorelin hydrochloride). Adlumiz was expected to be used to treat anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer.

The Committee adopted a negative opinion for Human IgG1 monoclonal antibody specific for human interleukin-1 alpha Xilonix. This medicine, from USA-based XBiotech (Nasdaq: XBIT) was intended to treat debilitating symptoms of advanced colorectal cancer.

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