Otsuka Pharmaceutical Co., Ltd. announces that on March 12, DELTYBA® Tablets 50 mg (generic name: delamanid) received regulatory approval by the China Food and Drug Administration. Approval was granted for the manufacture and marketing of DELTYBA as a treatment for multidrug-resistant, pulmonary tuberculosis (MDR-TB) in adults.
Infectious diseases account for approximately one-fourth of all deaths in the world every year. Among infectious diseases, tuberculosis is the largest single cause of death. In 2016, an estimated 1.7 million people died from tuberculosis while 10.4 million were newly infected.[i]
Seven countries accounted for 64% of the total TB burden in 2016, with India, Indonesia, China, the Philippines, Pakistan, Nigeria and South Africa having the highest estimated burdens in descending order.i In recent years the emergence of tuberculosis strains that are resistant to existing drug regimens has made treatment more difficult.
Delamanid was discovered by Otsuka Pharmaceutical and first received regulatory approval in 2014 in Japan and in the EU for the treatment of adult patients with MDR-TB as part of a combination treatment regimen. In 2014, the WHO published interim policy guidance on "The Use of Delamanid in the Treatment of Multidrug-Resistant Tuberculosis" and in 2015 delamanid was added to the WHO's Model List of Essential Medicines.[ii] Delamanid has already been used by patients in more than 70 countries.
Otsuka Pharmaceutical's Keiso Yamasaki, who leads its Global Tuberculosis Project Team, remarked, "Otsuka has pursued global R&D for many years to identify a treatment for tuberculosis. In China, which has the third-largest number of people with TB among all countries, an estimated 73,000 contract multidrug-resistant TB each year. We hope that the approval of DELTYBA as a new treatment can help serve as a foundation for the eradication of TB in China."
[i] World Health Organization, Global Tuberculosis Report 2017. Accessible at: http://apps.who.int/iris/bitstream/10665/259366/1/9789241565516-eng.pdf?ua=1
[ii] World Health Organization. The use of delamanid in the treatment of multidrug-resistant tuberculosis - interim policy guidance. 2014. Accessible at: http://apps.who.int/iris/bitstream/10665/137334/1/WHO_HTM_TB_2014.23_eng.pdf
Source: Otsuka