CHMP rejects delamanid (Otsuka) for Tuberculosis

On 25 July 2013, CHMP adopted a negative opinion, recommending the refusal of the marketing authorisation for Delamanid,(OPC 67683)from Otsuka, intended for the treatment of multi-drug resistant Tuberculosis. The CHMP considered that the duration of treatment in the main study (two months) was too short to establish the effectiveness of delamanid in treating tuberculosis when added to other anti-tuberculosis medicines. As Delamanid was to be used for at least six months the data from two months� treatment could not be used to predict the effectiveness of delamanid when given for six months. In addition, the results of the extension and follow-up studies could not be used to support the longer term use of Delamanid as the studies included only those patients who had agreed to take part and who might therefore not be representative of the patients as a whole. Finally, the CHMP was of the view that it was not possible from the data submitted to determine the most appropriate dosing for Delamanid.