DELTYBA 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.
Along with AIDS and malaria, it is considered one of the world's top three infectious diseases and continues to pose a significant threat to public health. Despite being treatable, an estimated 9.9 million people were diagnosed with TB in 2020 and 1.5 million died from it.*1 A major concern is the emergence of drug-resistant strains of the bacteria*2 responsible for the disease.
Someone has to do TB research because it is still a huge public health issue
Mycobacterium tuberculosis, which causes tuberculosis, requires prolonged treatment with multiple drugs to be fully cured. Its airborne nature, combined with its ability to easily mutate, makes it difficult to control, which in turn makes the development of effective therapeutics a challenging task.
When Otsuka Pharmaceutical started its drug discovery research in 1971, one of the main focus areas was infectious diseases, such as tuberculosis. At that time, a new drug for tuberculosis had just been released, leading to a halt in research and development efforts by researchers and institutions worldwide. It seemed as if the problem of TB had been solved. However, TB remained a serious public health issue across the globe, and research into it needed to continue. With that in mind, Otsuka Pharmaceutical began its research efforts.
The research was challenging and at times had to be put on hold. However, our researchers persisted and worked for many years, eventually discovering a substance with powerful anti-tuberculosis properties that were effective against strains of tuberculosis resistant to existing drugs.
Supplying treatment to patients worldwide
In 2014, after many years of research, DELTYBA, a treatment for multidrug-resistant pulmonary TB, was approved and launched in Europe and Japan. It was one of the first new drugs for this type of TB in almost 40 years and the first to be approved in Japan. In 2015, it was included in the WHO Model List of Essential Medicines.
In treating TB, inconsistent or disrupted medication schedules can lead to the development of Mycobacterium tuberculosis strains that are resistant to the drugs being used. This not only limits treatment options but also makes it harder to cure the disease. To expedite the drug's availability to patients and ensure its appropriate use, Otsuka collaborated with organizations dedicated to eradicating TB globally, in addition to obtaining approval in each country.
In 2016, Otsuka Nobel Products GmbH, a German subsidiary of Otsuka, entered into a public-private partnership agreement with the Global Drug Facility (GDF) of the Stop Tuberculosis Partnership*3 to provide drugs to over 100 countries and regions, including countries with a high incidence of TB.
In 2017, the company also signed a licensing agreement with R Pharm for the manufacturing and commercialization of DELTYBA in Russia and ten neighboring countries. The same year, an agreement was signed with Mylan (now Viatris) to expand its presence in countries with high TB prevalence, such as India and South Africa.
As a result, as of September 2022, DELTYBA is being marketed and used in over 120 countries and regions.
Tackling Childhood Tuberculosis
Each year, between 25,000 and 30,000 children worldwide develop multidrug-resistant TB*4, of which only 3 to 4% are diagnosed and treated, and approximately 21% of these children die.*5
The treatment of multidrug-resistant TB is challenging, and even more so for children. Therefore, a new formulation of Delamanid for pediatric patients was developed, which was approved by the European Commission in September 2021 for use in pediatric patients weighing 10 kg or more. In November of the same year, this formulation was also included in the WHO Model List of Essential Medicines. However, the fight is still ongoing, as we are currently working on the development of a new TB drug that works differently from DELTYBA.
We will always remember the need for continued research and will continue to combat the multidrug-resistant bacteria that still exist.
- *1World Health Organization. Global Tuberculosis Report 2021
- *2When 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).
- *3Established 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.
- *4Access to Medicine Foundation report "Tuberculosis in Children: Underdiagnosed and Undertreated" (2020)
- *5Helen E Jenkins and Courtney M Yuen (2018)
DELTYBA is a bactericidal agent with a novel mode of action that interferes with the metabolism of the Mycobacterium tuberculosis cell walls.
