Negative opinion for anamorelin hydrochloride

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On 18 May 2017, the CHMP adopted a negative opinion, recommending the refusal of the marketing authorisation for the the active substance anamorelin hydrochloride, intended for the treatment of anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer. The company requested a re-examination of the initial opinion. After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017. Anamorelin hydrochloride attaches to and activates a target on cells called a ghrelin receptor. Activation of the receptor causes release of substances in the body which are expected to act in the brain to increase appetite and prevent weight loss. 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 anamorelin hydrochloride or placebo 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 anamorelin hydrochloride 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 anamorelin hydrochloride was not possible. Therefore, the CHMP was of the opinion that the benefits of anamorelin hydrochloride did not outweigh its risks and recommended that it be refused marketing authorisation. The CHMP refusal was confirmed after re-examination.

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