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TAG Welcomes Delamanid’s Inclusion in the Stop TB Partnership’s Global Drug Facility

For Immediate Release
February 24, 2016
Contact: Erica Lessem, TB/HIV project director, +1.212.253.7922

Treatment Action Group (TAG) congratulates the Stop TB Partnership and Otsuka Pharmaceutical for arranging for the inclusion of delamanid, an important new medicine for treating some cases of multidrug-resistant tuberculosis (MDR-TB), in the Global Drug Facility (GDF). TB is the leading infectious cause of death globally, and new medicines to treat drug-resistant strains of TB are urgently needed. TAG commends the GDF and the Stop TB Partnership for their leadership in securing access to delamanid with minimal barriers and at a single flat price for all Global Fund-eligible countries.

“Delamanid’s inclusion in the Global Drug Facility catalogue is welcome news but could have happened almost two years ago,” said Mark Harrington, TAG’s executive director. “Availability and uptake of delamanid has been much too limited, especially given the enormous need for better options to treat drug-resistant tuberculosis.”

Delamanid (also known by its brand name, Deltyba) became only the second new TB drug from a new drug class to be approved in over forty years when the European Medicines Agency granted it conditional approval to treat MDR-TB in April 2014. Without new drugs such as delamanid, cure rates for drug-resistant TB range from under 30 percent for extensively drug-resistant (XDR) TB to under 70 percent for MDR-TB. An estimated one-third of the nearly half million people who develop MDR-TB each year may benefit from delamanid under the conditions of use recommended in guidance from the World Health Organization (WHO). Unlike the other new TB drug, bedaquiline, delamanid has been tested in children as young as six years of age, and results from an ongoing phase III trial are expected in 2018 that may result in broadened recommendations for its use. Yet almost two years postapproval, the drug has reached fewer than 200 patients outside of clinical trials. Otsuka, a leader in investing in TB R&D, was unconscionably slow to start delamanid’s compassionate use program and has registered the drug only in the European Union, Japan, and South Korea—areas in which relatively few people with MDR-TB live. Registration is pending in China and Hong Kong.

Providing delamanid through the GDF at a rate of US$1,700 per six-month treatment course is a major step toward universal access to this important drug. The GDF, under the auspices of the Stop TB Partnership, supplies high-quality products at negotiated rates to TB programs around the world, and, among other services, pools demand for TB medicines to create a more stable market for suppliers.

In other small but significant steps, Otsuka has removed the delamanid compassionate use program’s exclusion of pregnant women (based on the risk vs. benefit determination by the treating physician) and of people who are also in need of bedaquiline. TAG acknowledges Otsuka’s efforts to respond to community demands in opening its compassionate use access program to people otherwise out of treatment options.

 “Otsuka has taken important steps forward to expand access to delamanid, but equitable, widespread access to delamanid is urgently needed,” said Erica Lessem, TAG’s TB/HIV project director. “Otsuka must commit to registering delamanid in countries where people with MDR-TB actually live, particularly those like South Africa and Peru where it conducted clinical trials to facilitate delamanid’s registration in rich countries. In the meantime, countries now can—and must—obtain delamanid and other drugs to treat MDR-TB via the GDF using import waivers and other provisional mechanisms.”

TAG urges all TB programs to immediately implement WHO guidance and procure delamanid, as well as bedaquiline and important companion drugs linezolid and clofazimine, to ensure adequate treatment options for even difficult strains of MDR-TB. MDR-TB treatment and cure rates overall are unacceptable, with only about 20 percent of people with MDR-TB being put on treatment, of whom less than half are cured. Only by starting patients rapidly on effective treatment will we achieve global targets to end TB. And only by taking up new interventions such as delamanid will we send the appropriate signals to developers that investing in R&D for TB, and pricing drugs affordably, is essential.

For more information, please see TAG’s guide to delamanid here: http://www.treatmentactiongroup.org/tb/delamanid-factsheet.