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November 22, 2013    

CONTACT: Erica Lessem
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— Approval of and access to delamanid are crucial while further research is pending

NEW YORK, NY, USA – Treatment Action Group (TAG) congratulates the Committee for Medicinal Products for Human Use (CHMP) for its recommendation to the European Medicines Agency (EMA) to grant marketing approval to delamanid, a new drug for multidrug-resistant tuberculosis (MDR-TB) now in phase III clinical trials. MDR-TB treatment options that do not include new drugs are long, toxic, difficult to tolerate, and often ineffective.

Delamanid, which will be marketed under the name Deltyba, is just the second TB drug from a new drug class to receive approval from a stringent regulatory authority in four decades. In its opinion and accompanying fact sheet, issued November 21, the CHMP stated that it “considers there to be a favourable benefit to risk balance for Deltyba,” but does “recommended that an additional study should be carried out to confirm that the current recommended dose is the most appropriate dose.” A phase II study showed that those who took delamanid for six months (in addition to a background regimen) were 35 percent more likely to be cured than those who took a background regimen and delamanid for two months or less. Moreover, after two years of follow-up, those who took delamanid for six months were seven times more likely to survive.

“We applaud the EMA’s approval of delamanid given its evidence of safety and efficacy to date, and congratulate Otsuka on its research achievements so far,” said Mark Harrington, executive director of TAG. “However, we advise Otsuka that unless it provides rapid, affordable access to the drug, activists will take action.”

Otsuka has advanced delamanid rapidly through clinical trials, including critical pediatric trials. In contrast, Johnson & Johnson, the sponsor of the other new MDR-TB drug, bedaquiline, has yet to initiate its phase III or pediatric trial nearly a year after U.S. Food and Drug Administration approval.

Still, Otsuka has failed to provide pre-approval access to its compound or commit to an affordable pricing plan for delamanid where it is approved. “Otsuka’s refusal to allow pre-approval access to delamanid for patients in urgent need is a gross ethical and human rights violation, and does not bode well for its long-term access strategy,” said Wim Vandevelde, chair of the Global TB Community Advisory Board and member of the European AIDS Treatment Group. “The company needs to initiate a global compassionate use program immediately and commit to affordable pricing of delamanid.”

As EMA marketing approval does not translate into access in most countries where people with MDR-TB live, TAG urges Otsuka to institute compassionate use programs and expanded access studies immediately to ensure that treatment options are available to those in dire need.

TAG also encourages the U.S. National Institutes of Health to expedite its work to determine whether bedaquiline and delamanid can be used together safely and effectively, as patients and doctors need combinations of new drugs to prevent the development of resistance.

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Treatment Action Group is an independent AIDS research and policy think tank fighting for better treatment, a vaccine, and a cure for AIDS. TAG works to ensure that all people with HIV receive lifesaving treatment, care, and information. We are science-based treatment activists working to expand and accelerate vital research and effective community engagement with research and policy institutions. TAG catalyzes open collective action by all affected communities, scientists, and policy makers to end AIDS.


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