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