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Otsuka product development storiesDELTYBA Product story

Targeting TB elimination: Supplying MDR-TB medication to patients worldwide

Tuberculosis (TB) is one of the oldest and most persistent diseases in the world.
Even today, an estimated one-third of the world’s population is latently infected with TB bacteria.*1
Despite being curable, TB surpasses HIV/ AIDS as the most-deadly infectious disease.*2
In 2015 alone, 10.4 million people developed TB, and 1.8 million died from it.*2 Global progress in eliminating the disease is threatened by the spread of drug-resistant bacteria.*3

Someone has to do TB research because it is still a huge public health issue

TB, an airborne disease that is difficult to contain, also presents a tough challenge for medical researchers. Mycobacterium tuberculosis is difficult to kill because it hides inside human immune cells, frequently mutates and adapts to survive the effects of medicines, and therefore necessitates treatment with a combination of drugs over a prolonged period.
The release of a new TB drug in the 1960's led many researchers and institutions to halt TB drug development and shift to other diseases in the belief that the TB problem had been solved.
However, our late chairman, Akihiko Otsuka, and others at the company understood that TB remained a major public health threat, and that sustained research and innovation was vital. Despite the scientific challenges, Otsuka researchers were determined, and succeeded in identifying a substance that was highly effective against TB bacteria, including strains resistant to existing antibiotics.

Supplying treatment to patients worldwide

In 2014, this long period of research and development culminated in the approval, initially in the EU and Japan, of DELTYBA, a medication for treatment of adult pulmonary MDR-TB. DELTYBA is one of the first TB drugs to receive regulatory approval in almost 50 years.
Drug-resistant strains can develop when TB medications are not taken as prescribed, such as when doses are taken irregularly or when treatment is ended before the full course of antibiotics has been completed. The development of drug resistance severely limits treatment options for patients and decreases their chances for a successful treatment outcome. To help prevent reoccurrence of this problem and to quickly deliver DELTYBA to patients, Otsuka uses a two-pronged approach, applying for approval from regulatory authorities in various countries while working with organizations worldwide dedicated to fighting TB.
In 2016, Otsuka entered into an agreement with the Stop TB Partnership’s*4 Global Drug Facility (GDF), enabling distribution of DELTYBA to over 100 low-and middle-income countries. In addition to supplying the drug, training and technical support are provided to ensure that DELTYBA is used correctly and effectively incorporated into existing MDR-TB treatment programs. DELTYBA was added to the World Health Organization’s (WHO) Essential Medicines List in 2015, and as of February 2017, regulatory approval had been obtained in Japan, South Korea, Hong Kong and the EU, with applications pending in a number of high-burden countries, including China, Indonesia, and the Philippines.
Our fight against TB is not over. Otsuka is currently participating in a number of collaborative studies to optimize MDR-TB treatment using DELTYBA and is working on developing a new anti-TB compound for use in combination with DELTYBA as the backbone for a future pan-TB treatment regimen. Furthermore, Otsuka is currently conducting the first trials for an MDR-TB medicine for children using the first-ever child-friendly MDR-TB formulation. Otsuka remains driven by the belief that our company should continue research and development of drugs and other innovative technologies against TB. We must fight back against this persistent global health threat.

  1. 1People infected with TB bacteria but not yet ill with the disease and unable to transmit it
  2. 2WHO, Global Tuberculosis Report 2016
  3. 3 When TB bacteria become resistant to at least the two most commonly used first-line medicines, isoniazid and rifampicin, the infection is called multidrug-resistant (MDR). 480,000 people developed MDR-TB in 2015, with nearly half of the cases in India, China, and Russia. (WHO, Global TB Report 2016)
  4. 4Established in 2001 with the aim of eradicating tuberculosis. Participants include international organizations such as the WHO, government agencies, private enterprises, and patient groups. The Global Drug Facility was created as a subsidiary organization of the Stop TB Partnership to increase access to high-quality and affordable TB treatments & diagnostics.

DELTYBA

DELTYBA is a bactericidal agent with a novel mode of action that interferes with the metabolism of the Mycobacterium tuberculosis cell walls.