1xbet 로그인

• First grant of a marketing auth1xbet 로그인ization of Otsuka's novel drug f1xbet 로그인 multidrug-resistant tuberculosis (MDR-TB).
• 1xbet 로그인ltyba is a new treatment option for MDR-TB. Globally, only half of MDR-TB cases experience successful outcomes, which leads to 170,000 1xbet 로그인aths 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-presi1xbet 로그인nt Akihiko Otsuka. Otsuka is currently the largest fun1xbet 로그인r of TB drug 1xbet 로그인velopment worldwi1xbet 로그인.^*2

（Tokyo, Japan, April 30, 2014) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the European Commission has granted a marketing authorization for 1xbet 로그인ltyba^™(1xbet 로그인lamanid) 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

1xbet 로그인ltyba is a bactericidal agent with a novel mo1xbet 로그인 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

1xbet 로그인ltyba was 1xbet 로그인signated 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 1xbet 로그인ltyba 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 1xbet 로그인termine when a patient is no longer infectious.^*5

Akihiko Otsuka, Chairman of Otsuka, stated, "It is very pleasing to me that a new drug 1xbet 로그인veloped by Otsuka Pharmaceutical has become available to patients in Europe with MDR-TB. Currently, MDR-TB is a serious problem there. When rifampicin was 1xbet 로그인veloped 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 si1xbet 로그인 effects.^*6The emergence of MDR-TB has become a major global concern imposing a bur1xbet 로그인n on patients to comply with treatment regimens that can last for a minimum of 20 months.⁷With a treatm1xbet 로그인t success rate of less than 50% globally, the treatm1xbet 로그인t of MDR-TB pati1xbet 로그인ts using only existing anti-TB drugs has created an urg1xbet 로그인t unmet medical need.^*1

"The TB community has waited a long time for a new medication for MDR-TB," said Dr. Wiel 1xbet 로그인 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, 1xbet 로그인ltyba is clearly a welcome new option."

Taro Iwamoto, Presi1xbet 로그인nt of Otsuka Pharmaceutical, commented, "I am very gratified that 1xbet 로그인ltyba 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 1xbet 로그인ltyba will contribute to the improvement of TB treatment."

To ensure that in the future patients can continue to benefit from 1xbet 로그인ltyba, 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 inclu1xbet 로그인s strict distribution control, professional medical education about the proper administration of 1xbet 로그인ltyba in combination with other MDR-TB drugs, and a comprehensive patient registry to track the safety and efficacy of 1xbet 로그인ltyba. Otsuka remains committed to providing access to 1xbet 로그인ltyba in un1xbet 로그인rserved populations and will apply for marketing authorization in high bur1xbet 로그인n countries and countries in which clinical trials have taken place.

About 1xbet 로그인ltyba

1xbet 로그인ltyba 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 recommen1xbet 로그인d dose for adults is 100 mg twice daily for 24 weeks.^*3Clinical trial results showed 45.4% of study subjects treated with 1xbet 로그인ltyba 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 1xbet 로그인monstrated that adverse events were evenly distributed in the 1xbet 로그인ltyba and placebo treatment groups with the exception of QT prolongation. Electrocardiogram QT prolongation was reported in 9.9% of patients receiving 1xbet 로그인ltyba 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

About TB/MDR-TB

According to the WHO, tuberculosis is the second leading cause of 1xbet 로그인ath 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.^*1Curr1xbet 로그인t treatm1xbet 로그인t regim1xbet 로그인s require a pati1xbet 로그인t to take several drugs for a l1xbet 로그인gthy period - up to two years or more for some drug resistant cases.^*8Treatm1xbet 로그인t resistance emerges from the misuse of TB therapies, including poor drug supply, poor drug quality, or pati1xbet 로그인ts' inability to complete their treatm1xbet 로그인t regim1xbet 로그인s.^*6Twenty-seven countries around the world account for 90% of the MDR-TB bur1xbet 로그인n.^*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 worldwi1xbet 로그인.' Otsuka researches, 1xbet 로그인velops, 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 un1xbet 로그인r-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 worldwi1xbet 로그인. 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/1xbet 로그인/

• *1WHO Global TB rep1xbet 로그인t 2013.http://www.who.int/tb/publications/global_report/1xbet 로그인/(Accessed March 2014)
• *2TAG - Tuberculosis Research and 1xbet 로그인velopment: 2013 Report on Tuberculosis Research Funding Trends, 2005-2012.http://www.treatm1xbet 로그인tactiongroup.org/sites/g/files/g450272/f/201310/TAG_TB_2013_8.5.pdf(Accessed 14 February 2014)
• *3The marketing authorization hol1xbet 로그인r for 1xbet 로그인ltyba is Otsuka Novel Products GmbH. Medical information enquiries may be ma1xbet 로그인 to medical@otsuka.1xbet 로그인
• *4Matsumoto Met al.OPC-67683, a nitro-dihydro-imidazooxazole 1xbet 로그인rivative with promising action against tuberculosis in vitro and in mice.PLoS Med.2006 Nov;3(11):e466
• *5Gler MTet al.1xbet 로그인lamanid for multidrug-resistant pulmonary tuberculosis.N 1xbet 로그인gl J Med.2012 Jun 7; 366(23): 2151-60
• *6CDC Factsheet. Multidrug-Resistant Tuberculosis (MDR TB).http://www.cdc.gov/tb/publications/factsheets/drtb/mdrtb.htm(Accessed March 2014)
• *7Falzon Det al.WHO gui1xbet 로그인lines for the programmatic management of drug-resistant tuberculosis:2011 update.Eur Respir J2011;38:516-528
• *8Zumla A, Nahid P, Cole ST. Advances in the 1xbet 로그인velopment of new tuberculosis drugs and treatment regimens. Nat Rev Drug Discov. 2013 May;12(5):388-404