Deltyba® (delamanid) approved in the Russian Federation for the treatment of pulmonary MDR-TB

May 25
  • Deltyba® (delamanid) —an essential medicine according to the World Health Organization [1]—is now available in Russia for difficult-to-treat MDR-TB patients.
  • Deltyba® (delamanid), developed by Otsuka Pharmaceutical Co., Ltd. based in Japan, is commercialized in Russia by the R-Pharm group of companies.

Moscow, RUSSIA and Tokyo, JAPAN - 25, MAY 2020 – Otsuka Pharmaceutical Co., Ltd. (Otsuka) and R-Pharm JSC (R-Pharm) announce today that the oral anti-tuberculosis (TB) drug Deltyba® (delamanid) is approved in Russia. TB is an airborne, infectious disease, and drug-resistant infection makes treatment longer, more complicated, and lowers the chances of treatment success. The latest global treatment success rates for MDR-TB/Rifampicin-resistant TB (RR-TB) are less than 60 percent.[2]

Russia is one of the countries with the highest prevalence of MDR-TB, cited as a priority health issue by national health services. An integrated approach to TB management and high quality TB treatment centres have led to a steady downward trend in morbidity and mortality from TB. Nevertheless, the number of patients remains high with 79,000 people falling ill with TB in 2018 and 10,500 dying from the disease, according to the World Health Organization (WHO). With 41,000 cases of drug-resistant TB (MDR/RR-TB), Russia ranks third in the world in absolute number of cases after China and India.[2]

Thanks to coordination between the governments of Japan and Russia, Deltyba® (delamanid) became the first drug to receive marketing authorization in Russia following the Eurasian Economic Union registration procedure. Improving medical care and promoting healthy life spans was a key topic at the Eastern Economic Forum held in Vladivostok, Russia on September 7, 2017, where Japan’s Prime Minister Shinzo Abe stated: “In the fight against tuberculosis, Japan and Russia have joined hands.”

"This is an important step in Russian-Japanese partnership; helping patients with severe TB infection. R-Pharm is an integral part of the manufacturing strategy for Deltyba and conducts all necessary activities for appropriate clinical usage in Russia,” said Alexey Repik, Founder and President of R-Pharm Group.

“Strong collaboration between R-Pharm and Otsuka has helped us arrive at this major milestone,” added Robert Dornheim, CEO and managing director of Otsuka Novel Products GmbH, subsidiary of Otsuka and R-Pharm licensing collaborator. “We are pleased that our two companies have been able to work together for the benefit of all TB patients in Russia who now have a new therapeutic option available to help them battle this devastating disease.”

Deltyba® (delamanid) has potent bactericidal activity against Mycobacterium tuberculosis and is the first approved compound from the bicyclic nitro-imidazole derivatives for the treatment of pulmonary MDR-TB in adult patients. [3] It received regulatory approval in China, the European Union, Hong Kong, India, Indonesia, Japan, Kazakhstan, Mongolia, Peru, South Africa, South Korea, Philippines, Turkey, Turkmenistan, and Ukraine. Deltyba® (delamanid) is indicated in Russia for use as part of an appropriate combination regimen for pulmonary MDR-TB in adult patients.

About Deltyba®

Deltyba® (delamanid) has been in use since 2014 for the treatment of pulmonary MDR-TB in adult patients where it has been difficult to construct a regimen due to tolerability or resistance issues. It has exhibited anti-TB efficacy and a favourable safety profile in multiple Otsuka-sponsored clinical trials, including two Phase 2 studies, an open-label Registry (Trials 204/208/116), and one Phase 3 clinical trial (Trial 213).[4-6]

About Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy:  “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programmes in several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a big venture company at heart, applying a youthful spirit of creativity in everything it does.

In 2010 Otsuka Novel Products GmbH (ONPG) was established in Munich, Germany, as the marketing authorization holder in the European Union for Deltyba® (delamanid) dedicated to finding innovative solutions to fight the global TB pandemic. Working in collaboration with other Otsuka Group companies, partners, non-governmental organisations and other stakeholders, ONPG is expanding global access to Deltyba® (delamanid) to help fight MDR-TB.

All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Co., Ltd. at www.otsuka.co.jp/en/.

 


[1] World Health Organization. WHO moves to improve access to lifesaving medicines for hepatitis C, drug-resistant TB and cancers. 8 May 2015. (accessed 18/05/2020) http://www.who.int/mediacentre/news/releases/2015/new-essential-medicines-list/en/

[2] World Health Organization. Global tuberculosis report 2019. (accessed 18/05/2020) http://www.who.int/tb/publications/global_report/en/

[3] Matsumoto M, et al. OPC-67683, a nitro-dihydro-imidazooxazole derivative with promising action against tuberculosis in vitro and in mice. PLOS Med 2006; 3: e466.

[4] Gler M, et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med 2012; 366: 2151-2160.

[5] Skripconoka V, et al. Delamanid improves outcomes and reduces mortality in multidrug-resistant tuberculosis. Eur Respir J. 2013; 41:1393-400.

[6] von Groote-Bidlingmaier F, et al. Efficacy and safety of delamanid in combination with an optimised background regimen for treatment of multidrug-resistant tuberculosis: a multicentre, randomised, double-blind, placebo-controlled, parallel group phase 3 trial. Lancet Respir Med 2019; 7(3):249-259.

 

 

 

 

Other company news

R-Pharm Group announces positive results of CREDO 2, a pivotal global (1648 patients in 18 countries) Phase III clinical study of IL-6...
read more...
July 2
R-Pharm Holding, LLC (Headquarters: Moscow, Russia; Chairman: Alexey Repik, hereinafter R-Pharm) and Canon Medical Systems Corporation...
read more...
June 22
R-Pharm Group of Companies successfully registered Artlegia (olokizumab), a novel drug for treatment of rheumatoid arthritis in the first...
read more...
May 29