CHMP rebuffs Otsuka TB compound

EMA's CHMP issued a negative opinion recommending against approval of an MAA from Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) for delamanid to treat multidrug-resistant tuberculosis (MDR-TB) in combination with optimized background therapy. CHMP said the two-month treatment duration of delamanid in a Phase IIb trial was "too short to establish the effectiveness" over the background therapy and to "predict the effectiveness" of a six-month treatment duration. CHMP also said dosing for delamanid could not be determined from submitted data and that extension and follow-up trials could not be used to support a longer treatment duration for delamanid because enrolled patients may not be representative of the larger patient population.

Last year, Otsuka said twice-daily delamanid for two months in combination with standard background regimen met the primary endpoint vs. background therapy alone in a Phase IIb trial for MDR-TB. The pharma is conducting an international Phase III trial to evaluate delamanid for six months in patients with MDR-TB (see BioCentury Extra, June 7, 2012). ...