CHMP Declines to OK Delamanid for Multidrug-Resistant TB

Troy Brown


July 31, 2013

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency voted not to recommend marketing authorization for delamanid (Delamanid, Otsuka Novel Products GmbH), intended for the treatment of multidrug-resistant tuberculosis (TB), according to a July 25 EMA statement.

The company may request that the opinion be reexamined within 15 days of notification of the opinion.

Delamanid is an antibiotic intended for use in patients with multidrug-resistant TB (TB resistant to at least isoniazid and rifampicin) and would have been used together with other drugs. Delamanid interferes with methoxy-mycolic and keto-mycolic acid, essential components of the Mycobacterium tuberculosis cell walls, but its exact mode of action is not clear.

The decision was based on results of a primary study of 481 patients with multidrug-resistant TB. Patients were given delamanid or placebo for 2 months in addition to their other medications. The study's primary endpoint was the proportion of patients in whom the bacteria was eradicated from their sputum. Patients had the option of continuing delamanid treatment for an additional 6 months in an extension study. Most patients were also followed-up in a registry study for as long as 24 months after beginning the main study.

The committee determined that the benefits of delamanid were not sufficiently demonstrated in the study and that the 2-month duration of treatment in the primary study was too short to demonstrate its effectiveness when used with other anti-TB medications. Because the medication was intended to be used for at least 6 months, the data from 2 months' use could not accurately predict how effective it would be when used for 6 months. The extension and follow-up studies only included patients who agreed to participate, so the data from those studies might not be representative of the entire group and could not be used to determine the drug's effectiveness over the course of 6 months.

The CHMP also determined that the most appropriate dosing could not be established from the data submitted.

For these reasons, the committee determined that delamanid's benefits did not outweigh its risks and recommended against granting marketing authorization.

Patients who are currently in clinical trials with delamanid will still be allowed to continue treatment and are urged to contact their prescribing physician for more information.


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