A new initiative to enable developing countries to access delamanid -- one of two new life-saving drugs approved to combat multidrug-resistant (MDR) tuberculosis (TB) -- is today announced by the Stop TB Partnership and Otsuka, the drug's manufacturer.
The innovative public-private partnership will allow countries to access delamanid through the Stop TB Partnership's Global Drug Facility, which already supports the USAID donation for bedaquiline -the other recently approved drug for MDR-TB, manufactured by Janssen.
MDR-TB and extensively-drug resistant TB (XDR-TB) are increasing globally. While there are existing treatment regimens to battle both types of TB, treatment for MDR- and XDR-TB can last two years or more and is extremely expensive and toxic compared to treatment for regular, drug-susceptible TB. These two new MDR-TB drugs -- bedaquiline and delamanid -- are the first drugs in decades with potential to dramatically improve MDR-TB treatment outcomes and reduce the number of people who die from the disease.
Coordinated programmes to help access these new therapies are essential if the world is to meet the targets in the Global Plan to End TB 2016 -2020 and further the World Health Organization's (WHO) ambitious goal to end TB as a global health threat by 2035.
All countries eligible for financing through the Global Fund to Fight AIDS, TB and Malaria and follow WHO guidelines for the proper management of MDR-TB in quality-assured programs can procure delamanid through the Global Drug Facility.
"As the largest purchaser of TB medicines for more than 100 countries, the Global Drug Facility is uniquely positioned, through coordination with public and private sectors, to catalyse uptake of new medicines and increase the speed and extent to which new TB innovations reach those who need them", said Dr Brenda Waning, Chief of the Global Drug Facility.
Delamanid will be supplied at a price of US$ 1700 for each full-course treatment of six months' duration. The Stop TB Partnership Secretariat teams and partners will provide advocacy, technical assistance, and other services to ensure adequate financing and accelerated introduction of delamanid into national TB programs.
The public-private partnership to expedite access to delamanid will be announced and discussed at a high-level panel discussion to be held on the side of an experience-sharing workshop on the introduction of new drugs for drug-resistant TB treatment in the World Health Organization's Southeast Asian and Western Pacific regions, taking place in Bangkok, Thailand, on February 24. The panel will bring together experts from the Stop TB Partnership's Global Drug Facility, TB survivors, WHO Geneva, Otsuka, Janssen, and other partners to discuss how the Global Drug Facility can best work with partners to ensure increased access of these new drugs to people with MDR-TB and XDR TB as quickly and as safely as possible.
Nearly half a million people each year develop MDR-TB, and of those diagnosed and enrolled in treatment, only 50% are successfully treated. "We are committed to enhancing access to delamanid, especially in high-burden countries, while ensuring responsible use of this medicine," said Masuhiro Yoshitake, Executive Operating Officer of Otsuka and TB Global Project Leader. "This public-private partnership with Stop TB is another step forward towards realizing the goal of TB elimination."
Commenting on this new partnership, Ross Underwood, Global Access Commercial Leader from Janssen said, "The GDF plays a pivotal role in the global bedaquiline access program by virtue of its global reach, provision of quality-assured drugs, and stewardship of responsible access.
We are pleased to see that the GDF will expand patient access to much needed additional treatment options and look forward to continue working together toward our mutual goal of eradicating TB."
"I think that as a TB community we need speed and a different mindset: we have 2 new drugs that can improve MDR and XDR-TB treatment outcomes -- we need to make sure that these are used by all those that need them -- responsibly and safely -- but we must move on! We spoke about a paradigm shift in the Global Plan -- this is one of the many steps we will do as Stop TB to accelerate our advance towards ending TB," said Dr Lucica Ditiu, Executive Director of the Stop TB Partnership.