The European Commission has approved marketing authorization for delamanid (Deltyba, Otsuka Pharmaceutical Co, Ltd) for the treatment of adults with pulmonary multidrug-resistant tuberculosis (TB). Delamanid is approved for use as part of an appropriate combination regimen when an effective treatment regimen is unavailable because of resistance or intolerability to other medications. Recommended dosing is 100 mg twice daily for 24 weeks.
Multidrug resistance (MDR) to anti-TB drugs is a major problem worldwide. It occurs for various reasons, including failure to complete a full course of treatment, which can last at least 20 months.
"I am very gratified that Deltyba has been granted a marketing authorization as a first-in-class, anti-TB drug in Europe.... There are still many patients throughout the world who suffer from MDR-TB," Taro Iwamoto, president of Otsuka Pharmaceutical, said in a company press release.
Delamanid works by interfering with the metabolism of the Mycobacterium tuberculosis cell walls. It has demonstrated high activity in vitro against M tuberculosis strains that are resistant to first-line anti-TB drugs, including isoniazid and rifampicin. Delamanid was given orphan medicine status in 2008.
The approval follows a review of data from clinical trial results in 9 countries. Those trials demonstrated that patients treated with delamanid, 100 mg twice daily, combined with an optimized background regimen (OBR) experienced a statistically significant increase in sputum culture conversion after 2 months (45.4% of patients) compared with those receiving placebo plus OBR (29.6% of patients). Sputum culture conversion indicates when a patient is no longer infectious.
Adverse events were evenly distributed between the drug and placebo groups, with the exception of electrocardiogram QT prolongation, which was reported in 9.9% of patients in the treatment group and 3.8% of patients in the placebo plus OBR group. There were no reports of clinical symptoms, such as syncope or arrhythmias.
In July 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) voted against recommending marketing approval for delamanid, in part because the clinical trial studied patient response for only 2 months and the drug is intended to be used for 6 months.
After consulting with infectious disease experts, the CHMP decided that clinical response at 2 months was a likely indication of the drug's effectiveness at 6 months. In November 2013, the CHMP granted conditional approval pending additional safety, efficacy, and dosing studies.
Otsuka is working to create a responsible access program that will help prevent the possible emergence of resistance to delamanid. The program includes strict control of distribution, professional medical education about appropriate use, and a comprehensive patient registry for tracking the drug's safety and efficacy. The company plans to provide access to underserved populations and will seek marketing authorization in high-burden countries and those in which clinical trials have been conducted.
Delamanid has not been approved for use in the United States.
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Cite this: Delamanid (Deltyba) Approved for Multidrug-Resistant TB in Europe - Medscape - May 01, 2014.