European Approval of Delanamid, a new drug to fight TB: MSF & TAG’s responses

MSF Responds to EMA approval of new tuberculosis drug delamanid


On November 22, 2013, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting a conditional marketing authorisation for delamanid, only the second new TB drug to be developed in 50 years.  It is hoped that the new drug, marketed by the Japanese company Otsuka, will be pivotal in improving treatment for drug-resistant forms of tuberculosis, including multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB).  Current treatment regimens for drug-resistant forms of the disease–which are highly toxic, lengthy, expensive and effective only half the time–are entirely insufficient to mount an effective response to the disease.

Otsuka’s Phase III clinical trials for delamanid are now underway.  The CHMP decision means that the drug can be marketed in European Union Member States for the treatment of adult patients with pulmonary infections due to multidrug-resistant tuberculosis when an effective treatment regimen cannot otherwise be devised for reasons of resistance or tolerability.  Some EU countries, including Bulgaria, Estonia, Latvia, Lithuania and Romania, have very high rates of MDR-TB.

MSF response:

“EMA’s approval is a landmark decision and a critical step towards better options for people in desperate need of more effective and safer treatments for drug-resistant tuberculosis, but this is only one piece of the solution.  What patients really need are all-new multidrug regimens, and clinical trials to test delamanid with other TB medicines are urgently needed if we are to radically improve treatment options.

To accelerate access and fully realise the potential of this new drug, we need open collaboration to test new multi-drug regimens, we need the drug to be registered widely especially in high-burden countries, and we need assurances that the drug won’t be priced out of reach of national TB programs.

In the meantime, seriously ill patients who have exhausted all other treatment options could be helped today if early access to the drug was made available through ‘compassionate use’ programs, and we hope Otsuka considers opening such a program.”

– Dr. Jennifer Cohn, Medical Coordinator, MSF Access Campaign

Treatment Action Group Applauds European Approval of New Drug to Fight Tuberculosis, Demands Expanded Access and Affordable Pricing

— 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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