Otsuka’s Drug-Resistant TB Treatment Fails to Win EMA Nod

Otsuka Holdings Co. failed to win the backing of a European Medicines Agency panel for the Delamanid medicine for tuberculosis that resists treatment with other drugs.

The benefits of Delamanid hadn’t been sufficiently shown, the agency’s Committee for Medicinal Products for Human Use said today in a statement following its monthly meeting. The duration of treatment in the main study the Tokyo-based company presented was two months, too short to establish the medicine’s effectiveness, the committee said.

Tuberculosis, the world’s deadliest infectious disease after AIDS, killed 1.4 million people in 2011, according to the World Health Organization. While TB can be cured with antibiotics, strains of the bacterium that resist most drugs afflict about 630,000 people worldwide, the WHO said. Delamanid was intended to be given to patients whose disease no longer responded to isoniazid and rifampicin, two standard therapies, according to the EMA.

Delamanid works by blocking the production of mycolic acid, a key component of the dense, waxy shell that encases the tuberculosis bug and helps it resist penicillin and most antibiotics. A study published in the New England Journal of Medicine last year showed the drug helped fight tuberculosis strains not stopped by other medications.

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