EU Regulators Okay 2 Drugs for Drug-Resistant TB

Disclosures

November 22, 2013

European Union (EU) regulators have recommended approval of 2 drugs to treat multidrug-resistant tuberculosis (TB) after having turned down one of them just 4 months earlier, the European Medicines Agency (EMA) announced today.

The 2 TB drugs, delamanid (Deltyba, Otsuka Novel Products GmbH) and para-aminosalicylic acid (Para-aminosalicylic acid Lucane, Lucane Pharma), represent the new and the old.

Delamanid, the newcomer, is an antibiotic that kills Mycobacterium tuberculosis by blocking the production of essential components of the bacterium's cell wall. It is indicated in combination with other drugs for patients with pulmonary, multidrug-resistant TB — that is, TB resistant to at least isoniazid and rifampicin.

In July, the EMA's Committee for Medicinal Products for Human Use (CHMP) voted not to recommend market approval for delamanid. The committee reasoned that a 2-month trial involving 481 patients with drug-resistant TB was too brief to demonstrate the product's effectiveness, especially because it was designed for a 6-month regimen. Also, CHMP said that the data submitted did not establish the most appropriate dosing. Accordingly, the drug's benefits were not deemed sufficient to outweigh the risks.

The manufacturer asked CHMP to reconsider its decision and limited the proposed indication of delamanid to pulmonary TB. Advised by a group of infectious disease experts, the committee determined that the drug's effectiveness at 2 months probably predicted its effectiveness at 6 months. CHMP granted conditional approval to delamanid provided it prove itself in several studies going forward — one to examine the drug's performance at 6 months, a second to confirm its long-term safety, and a third to confirm that the recommended dose is indeed on target.

Delamanid is not approved for use in the United States.

Para-aminosalicylic acid, the other TB drug greenlighted by CHMP, debuted in the 1940s but fell out of favor in the 1970s when more effective TB drugs came on the scene. However, the rise of multidrug-resistant TB gave para-aminosalicylic acid a new lease on life in the 1990s. In the United States, this drug is marketed under the brand name Paser (Jacobus Pharmaceutical Co). Like delamanid, para-aminosalicylic acid is part of a multidrug regimen.

CHMP's recommendation to approve para-aminosalicylic acid and delamanid now go to the European Commission, the executive branch of the EU, for a final decision.

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