April 30, 2014
Otsuka Pharmaceutical Co., Ltd.
Otsuka Wins European Marketing Authorization for Deltyba™ (delamanid)
- First grant of a marketing authorization of Otsuka's novel drug for multidrug-resistant tuberculosis (MDR-TB).
- Deltyba is a new treatment option for MDR-TB. Globally, only half of MDR-TB cases experience successful outcomes, which leads to 170,000 deaths annually, according to WHO.*1
- TB was one of the first research areas pursued by Otsuka's research institute when it was established in 1971 by then-president Akihiko Otsuka. Otsuka is currently the largest funder of TB drug development worldwide.*2
（Tokyo, Japan, April 30, 2014) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the European Commission has granted a marketing authorization for Deltyba™ (delamanid) for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.*3
Deltyba is a bactericidal agent with a novel mode of action that interferes with the metabolism of the Mycobacterium tuberculosis (MTB) cell walls. It also has high activity in vitro against various MTB strains, including those resistant to first-line anti-TB drugs, such as isoniazid and rifampicin.*4
Deltyba was designated as an orphan medicine in 2008 meaning that it is a medicine used to treat a rare disease. Clinical trial results from 9 countries showed that study subjects treated with Deltyba 100mg twice daily together with an optimized background regimen (OBR) achieved a statistically significant increase in sputum culture conversion (SCC) after two months (45.4% of study subjects) compared to those treated with a placebo (29.6% of study subjects). SCC is a measurement used to determine when a patient is no longer infectious.*5
Akihiko Otsuka, Chairman of Otsuka, stated, "It is very pleasing to me that a new drug developed by Otsuka Pharmaceutical has become available to patients in Europe with MDR-TB. Currently, MDR-TB is a serious problem there. When rifampicin was developed half a century ago, it seemed that the world's TB problem was over. But I specifically selected TB as a research theme for our company. I knew that someone had to do this research because TB was still a huge public health issue in Asia."
Resistance to anti-TB drugs can occur for a number of reasons including misuse or mismanagement, such as failure to complete a full course of treatment due to potential side effects.*6 The emergence of MDR-TB has become a major global concern imposing a burden on patients to comply with treatment regimens that can last for a minimum of 20 months.7 With a treatment success rate of less than 50% globally, the treatment of MDR-TB patients using only existing anti-TB drugs has created an urgent unmet medical need.*1
"The TB community has waited a long time for a new medication for MDR-TB," said Dr. Wiel de Lange, an MDR-TB expert at the University Medical Center in Groningen, the Netherlands. "With increasing rates of resistance to existing medications and globally less than half of all MDR-TB cases successfully treated, Deltyba is clearly a welcome new option."
Taro Iwamoto, President of Otsuka Pharmaceutical, commented, "I am very gratified that Deltyba has been granted a marketing authorization as a first-in-class, anti-TB drug in Europe - a dream we have held since the establishment of our research institute. There are still many patients throughout the world who suffer from MDR-TB. I hope Deltyba will contribute to the improvement of TB treatment."
To ensure that in the future patients can continue to benefit from Deltyba, Otsuka has invested in the creation of a Responsible Access Programme (RAP) to help safeguard against the possible emergence of resistance to the medicine. The RAP includes strict distribution control, professional medical education about the proper administration of Deltyba in combination with other MDR-TB drugs, and a comprehensive patient registry to track the safety and efficacy of Deltyba. Otsuka remains committed to providing access to Deltyba in underserved populations and will apply for marketing authorization in high burden countries and countries in which clinical trials have taken place.
Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. The recommended dose for adults is 100 mg twice daily for 24 weeks.*3 Clinical trial results showed 45.4% of study subjects treated with Deltyba 100 mg twice daily plus OBR, achieved sputum culture conversion (SCC), a measurement by which a patient is no longer infectious, after two months compared to 29.6% of those treated with placebo plus OBR, representing a statistically significant 53% increase.*5
Clinical trial results demonstrated that adverse events were evenly distributed in the Deltyba and placebo treatment groups with the exception of QT prolongation. Electrocardiogram QT prolongation was reported in 9.9% of patients receiving Deltyba as 100 mg twice daily compared to 3.8% of patients receiving placebo plus OBR. This was not accompanied by any clinical symptoms such as syncope or arrhythmias.*5
According to the WHO, tuberculosis is the second leading cause of death among infectious diseases. Every year, approximately 8.6 million people become sick, and nearly 1.3 million people die from TB or TB-related causes.*1 Current treatment regimens require a patient to take several drugs for a lengthy period - up to two years or more for some drug resistant cases.*8 Treatment resistance emerges from the misuse of TB therapies, including poor drug supply, poor drug quality, or patients' inability to complete their treatment regimens.*6 Twenty-seven countries around the world account for 90% of the MDR-TB burden.*1
About Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd. 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 and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leading firm in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate more powerfully than words how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The chairman Akihiko Otsuka is the third generation of Otsuka family members to lead the business, whose origins date from 1921. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Consolidated sales were approximately USD 13 billion for fiscal year 2012 (4/1/2012-3/31/2013). Otsuka Pharmaceutical warmly invites you to visit its global website at https://www.otsuka.co.jp/en/
- *1 WHO Global TB report 2013. http://www.who.int/tb/publications/global_report/en/ (Accessed March 2014)
- *2 TAG - Tuberculosis Research and Development: 2013 Report on Tuberculosis Research Funding Trends, 2005-2012. http://www.treatmentactiongroup.org/sites/g/files/g450272/f/201310/TAG_TB_2013_8.5.pdf (Accessed 14 February 2014)
- *3 The marketing authorization holder for Deltyba is Otsuka Novel Products GmbH. Medical information enquiries may be made to email@example.com
- *4 Matsumoto M et al. OPC-67683, a nitro-dihydro-imidazooxazole derivative with promising action against tuberculosis in vitro and in mice. PLoS Med. 2006 Nov;3(11):e466
- *5 Gler MT et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med. 2012 Jun 7; 366(23): 2151-60
- *6 CDC Factsheet. Multidrug-Resistant Tuberculosis (MDR TB). http://www.cdc.gov/tb/publications/factsheets/drtb/mdrtb.htm (Accessed March 2014)
- *7 Falzon D et al. WHO guidelines for the programmatic management of drug-resistant tuberculosis:2011 update. Eur Respir J 2011;38:516-528
- *8 Zumla A, Nahid P, Cole ST. Advances in the development of new tuberculosis drugs and treatment regimens. Nat Rev Drug Discov. 2013 May;12(5):388-404
Information in this news release was current as of the original release date.