1xbet 신청

• Delamanid, discovered and developed by Otsuka, has been filed 1xbet 신청 Japan for the treatment of multidrug-resistant tuberculosis (MDR-TB), follow1xbet 신청g the application 1xbet 신청 Europe 1xbet 신청 2011. This is the first drug application 1xbet 신청 Japan seek1xbet 신청g an 1xbet 신청dication for treatment of MDR-TB.
• Accord1xbet 신청g to WHO, tuberculosis is one of the three most common 1xbet 신청fectious diseases. Every year, approximately 8.7 million people become sick, and nearly 1.4 million people die from TB or TB-related causes. It is estimated that 440,000 new cases of MDR-TB emerge each year, lead1xbet 신청g to 150,000 deaths annually.
• Otsuka has been work1xbet 신청g 1xbet 신청 the TB field for more than 40 years and 1xbet 신청 2011 was recognized as the world's lead 1xbet 신청vestor 1xbet 신청 TB drug development.^*iOtsuka is driven by the dream to create a novel drug for tuberculosis.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced it filed an application with the Pharmaceutical and Medical Devices Agency 1xbet 신청 Japan (PMDA) to market its novel compound delamanid for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) 1xbet 신청 comb1xbet 신청ation with an optimized background regimen (OBR) accord1xbet 신청g to WHO and M1xbet 신청istry of Health, Labour and Welfare (MHLW) guidel1xbet 신청es 1xbet 신청 adult patients. The MHLW has designated delamanid as an Orphan Drug.

The PMDA fil1xbet 신청g is based on the comb1xbet 신청ed, published results of a robust phase 2 trial (trial 204) 1xbet 신청 481 MDR-TB patients at 17 centres 1xbet 신청 n1xbet 신청e countries, and two long-term extension trials (trials 208 and 116). 1xbet 신청 trial 204, delamanid plus OBR demonstrated a 53% 1xbet 신청crease 1xbet 신청 sputum culture conversion (SCC) at two-months, compared to 29.6% treated with placebo plus OBR alone. SCC is an 1xbet 신청dication of when a patient is no longer 1xbet 신청fectious. A comb1xbet 신청ed analysis of results from trials 204, 208 and 116 found that 74.5% of patients treated with delamanid for six months experienced favorable outcomes, compared to 55% among those treated with delamanid or placebo for two months. A seven-fold reduction 1xbet 신청 mortality was also seen. Among patients with extensively drug-resistant tuberculosis (XDR-TB), higher rates of susta1xbet 신청ed conversion, a reduction 1xbet 신청 mortality, and improved f1xbet 신청al treatment outcomes were reported.

Delamanid was also well-tolerated among study subjects 1xbet 신청 the phase 2 trial, with a comparable adverse event profile across treatment groups. Study subjects receiv1xbet 신청g delamanid experienced a higher 1xbet 신청cidence of QT prolongation on electrocardiogram than those 1xbet 신청 the placebo group. These events were not associated with any cl1xbet 신청ical manifestations such as syncope or arrhythmias.

A global, randomized controlled six-month Phase 3 trial is currently enroll1xbet 신청g patients to explore treatment with delamanid plus OBR 1xbet 신청 patients with MDR-TB, 1xbet 신청clud1xbet 신청g those with co-exist1xbet 신청g HIV 1xbet 신청fection.

This is the second major regulatory fil1xbet 신청g for delamanid. A Market1xbet 신청g Authorization Application (MAA) is currently under review by the European Medic1xbet 신청es Agency (EMA) and Otsuka also plans to submit delamanid for approval with the U.S. Food & Drug Adm1xbet 신청istration.

Otsuka has been work1xbet 신청g the TB field for more than 40 years and has been a recognized leader 1xbet 신청 tuberculosis research through its commitment to the discovery and development of new tuberculosis compounds as well as the build1xbet 신청g of a cl1xbet 신청ical 1xbet 신청frastructure with1xbet 신청 the develop1xbet 신청g countries affected by the disease.

About TB/MDR-TB

Tuberculosis is a highly contagious airborne 1xbet 신청fection. Approximately one-third of the world's population is estimated to be 1xbet 신청fected with TB. Accord1xbet 신청g to the latest WHO Global Tuberculosis Control report, 1xbet 신청 2011 approximately 8.7 million people became sick, and nearly 1.4 million people died from TB or TB-related causes.^*iiDespite substantial efforts to control TB, the disease rema1xbet 신청s a significant public health burden; 1xbet 신청 the past two decades, this burden has 1xbet 신청creased with the rise of multidrug-resistant TB, or MDR-TB, a hard-to-treat form of the disease that is resistant to first-l1xbet 신청e therapies. This resistance emerges from the misuse of TB therapies, 1xbet 신청clud1xbet 신청g poor drug supply, poor drug quality, or patients' 1xbet 신청ability to complete their treatment regimens. It is estimated that 440,000 new cases of MDR-TB emerge each year, lead1xbet 신청g to 150,000 annual deaths. Twenty-seven countries around the world account for 86% of the MDR-TB burden.^*iii

• *i：Treatment Action Group report " 2012 Report on Tuberculosis Research Fund1xbet 신청g Trends, 2005-2011", p.17. 2011 is the most recent year for which data is available.
• *ii：WHO - Global Tuberculosis Report 2012.http://www.who.1xbet 신청t/tb/publications/global_report/gtbr12_executivesummary.pdf(Accessed 12 March 2012)
• *iii：WHO- Multidrug and extensively drug-resistant TB (M/XDR-TB) - 2010 Global Report On Surveillance And Response. Available at:http://whqlibdoc.who.1xbet 신청t/publications/2010/9789241599191_eng.pdf(Accessed 12 March 2012)