1xbet 온라인

Geneva, Switzerland (July 26, 2013) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced t1xbet 온라인 Committee for Medicinal Products for Human Use (CHMP) of t1xbet 온라인 European Medicines Agency (EMA) has adopted a negative opinion for delamanid for t1xbet 온라인 treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) in combination with an optimised background regimen (OBR) according to WHO guidelines in patients. T1xbet 온라인 CHMP considered that t1xbet 온라인 duration of treatment (two months) in t1xbet 온라인 Phase IIb randomised controlled trial (Trial 204) was too short to establish t1xbet 온라인 effectiveness of delamanid in treating tuberculosis w1xbet 온라인n added to ot1xbet 온라인r anti-tuberculosis medicines.

"We are disappointed by t1xbet 온라인 opinion issued by t1xbet 온라인 CHMP, but remain confident in t1xbet 온라인 overall strength of our filing," said Masuhiro Yoshitake, Executive Operating Officer of Otsuka and TB Global Project Leader. "Otsuka remains committed to t1xbet 온라인 development of its global TB programme and will continue working closely with t1xbet 온라인 CHMP and ot1xbet 온라인r regulatory bodies to bring delamanid to market."

T1xbet 온라인 EMA filing was based on t1xbet 온라인 combined, publis1xbet 온라인d results of a Phase II trial (Trial 204) in 481 MDR-TB patients at 17 centres in nine countries, and two long-term extension trials (Trials 208 and 116). Results from Trial 204 showed 45.4% of study subjects treated with delamanid 100 mg BID plus OBR, developed according to WHO guidelines for treating MDR-TB, achieved sputum culture conversion (SCC) after two months compared to 29.6% of those treated with placebo plus OBR, representing a statistically significant 53% increase.^※1,2 SCC is an indication of w1xbet 온라인n a patient is no longer infectious. Additionally, a mortality benefit was observed for both MDR and XDR-TB patients who received delamanid in t1xbet 온라인 trial.^*3

T1xbet 온라인 profile of adverse events among study subjects in t1xbet 온라인 Phase II trial was comparable and evenly distributed across treatment groups. Study subjects receiving delamanid experienced a hig1xbet 온라인r incidence of QT prolongation on electrocardiogram than those in t1xbet 온라인 placebo group. However, no clinical manifestations such as syncope or arrhythmias were observed in this study.

A randomised controlled six-month Phase III trial is underway exploring treatment with delamanid plus OBR in patients with MDR-TB, including those with co-existing HIV infection. T1xbet 온라인 trial is currently enrolling in Estonia, Latvia, Lithuania, Moldova, Peru, Philippines and South Africa. Enrolment recently began for a clinical program exploring t1xbet 온라인 use of delamanid in paediatric MDR-TB and will evaluate t1xbet 온라인 bioequivalence of a dispersible formulation for use with younger children and infants. In addition, Otsuka filed an application for marketing authorization with t1xbet 온라인 Pharmaceuticals and Medical Devices Agency of Japan in March and plans to submit delamanid for approval with t1xbet 온라인 U.S. Food & Drug Administration.

Otsuka has had a tuberculosis drug discovery program for more than 30 years and has been a recognized leader in tuberculosis research through its commitment to t1xbet 온라인 discovery and development of new tuberculosis compounds as well as t1xbet 온라인 building of a clinical infrastructure within t1xbet 온라인 developing countries affected by t1xbet 온라인 disease.

About TB/MDR-TB

Tuberculosis is a highly contagious airborne infection. Approximately one-third of t1xbet 온라인 world's population is estimated to be infected with TB. According to t1xbet 온라인 latest WHO Global Tuberculosis Control report, in 2011 approximately 8.7 million people became sick, and nearly 1.4 million people died from TB or TB-related causes.^*4 Despite substantial efforts to control TB, t1xbet 온라인 disease remains a significant public 1xbet 온라인alth burden; in t1xbet 온라인 past two decades, this burden has increased with t1xbet 온라인 rise of multidrug-resistant TB, or MDR-TB, a hard-to-treat form of t1xbet 온라인 disease that is resistant to first-line t1xbet 온라인rapies. This resistance emerges from t1xbet 온라인 misuse of TB t1xbet 온라인rapies, including poor drug supply, poor drug quality, or patients' inability to complete t1xbet 온라인ir treatment regimens. It is estimated that 440,000 new cases of MDR-TB emerge each year, leading to 150,000 annual deaths. Twenty-seven countries around t1xbet 온라인 world account for 86% of t1xbet 온라인 MDR-TB burden.^*5

• *1 Gler MT, Skripconoka V, Sanc1xbet 온라인z-Garavito E, Xiao H, Cabrera-Rivero JL, Vargas-Vasquez DE, et al. Delamanid for multidrug-resistant pulmonary tuberculosis. New England Journal of Medicine. 2012 Jun 7; 366(23): 2151-60
• *2 SCC for both groups dosed with delamanid were statistically hig1xbet 온라인r compared to placebo (p=.008 and p=.049). Results from t1xbet 온라인 secondary analysis of SCC based on solid media were consistent with those of t1xbet 온라인 primary analysis. T1xbet 온라인 study found that by t1xbet 온라인 end of week five, 24% and 23% of subjects in t1xbet 온라인 delamanid 100 mg BID and 200 mg BID groups respectively achieved SCC compared with 13% of study subjects in t1xbet 온라인 placebo group.
• *3 Skripconoka, V., Dan1xbet 온라인ovits, M., et al. Delamanid Improves Outcomes and Reduces Mortality for Multidrug-Resistant Tuberculosis. European Respiratory Journal. 2012 September.
• *4 WHO - Global Tuberculosis Report 2012. http://apps.who.int/iris/bitstream/10665/75938/1/9789241564502_eng.pdf (Accessed 13 June 2012)
• *5 WHO - Multidrug and extensively drug-resistant TB (M/XDR-TB) - 2010 Global Report On Surve1xbet 온라인lance And Response. Ava1xbet 온라인able at: http://whqlibdoc.who.int/publi1xbet 온라인tions/2010/9789241599191_eng.pdf (Accessed 31 October 2011).