CHMP denies B-MS and Santhera drugs

At its late-November meeting, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion for Bristol-Myers Squibb's Ixempra (ixapebilone) and confirmed its previous rejection of Swiss firm Santhera's Sovrima (idebenone).

Ixempra was intended to treat locally-advanced or metastatic breast cancer by infusion, when treatment with cytotoxic medicines had failed, either in combination with capecitabine or as monotherapy. The CHMP said it is concerned that the "very small" increase in survival rates offered by the drug and only a marginal extension of time to progression did not outweigh the risk of neuropathy, a severe and common side effect noted in trials of the drug.

Sovrima was submitted for evaluation earlier this year (Marketletter July 28) as a treatment for Friedreich's Ataxia, but was turned down as the CHMP said it could not consider the application whilst late-stage trials with the drug were ongoing under the EMEA Guideline on Clinical Trials in Small Populations. Santhera had requested a re-evaluation, but the Committee re-enforced its decision at the November meeting.