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Otsuka wins EU marketing authorization for TB drug

Co., Ltd. has announced that the European Commission has granted a marketing authorization for DeltybaTM (delamanid) for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis () 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.

About Deltyba

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

Source

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 protected]

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

Otsuka Pharmaceutical Co., Ltd.