Ixempra (ixabepilone) was expected to be used to treat locally advanced or metastatic breast cancer after failure of previous cytotoxic chemotherapy treatments. It was to be used in combination with capecitabine.
The application for the marketing authorisation for Ixempra was submitted to the Agency on 24 September 2007. On 20 November 2008, the Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation. Following this, the company requested a re-examination of the opinion, which was under review by the CHMP at the time of the withdrawal.
The company stated in its official letter that the withdrawal of application for Ixempra was based on the fact that the information provided in the re-examination procedure did not provide the Committee with sufficient evidence to change the benefit-risk balance.
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