CHMP backs TB compounds from Otsuka, Lucane

EMA's CHMP on Friday recommended approval of two compounds for multidrug-resistant tuberculosis (MDR-TB) -- Deltyba delamanid from Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) and Para-aminosalicylic acid Lucane from Lucane Pharma S.A. (Paris, France). The committee backed conditional approval of Deltyba to treat pulmonary infections due to MDR-TB in adults when alternative treatments cannot be used due to resistance or intolerance. The recommendation reverses a July negative opinion from CHMP, but only for a restricted patient population.

In July, CHMP had recommended against approval of delamanid for MDR-TB, in part over concern that the two-month treatment duration of delamanid in a Phase IIb trial was "too short" to establish the effectiveness over the background therapy and "predict the effectiveness" of a six-month treatment duration. Otsuka subsequently restricted the use of delamanid to TB affecting the lungs and requested a reexamination. CHMP said that after consulting with experts and literature, it is "considered likely" that the data from two-month treatment duration predict effectiveness at six months, and that the compound's benefits outweigh its risks for the restricted population (see BioCentury Extra, July 26). ...