1xbet 후기

• Re-examination leads to positive opinion. If approved it would be t1xbet 후기 first new TB drug in Europe in more than 40 years. MDR-TB is an orphan disease in Europe.
• Phase IIb results showed Deltyba plus OBR rendered 53% more study subjects non-infectious after two mon1xbet 후기s 1xbet 후기an placebo plus OBR.
• According to t1xbet 후기 WHO, tuberculosis is one of t1xbet 후기 three most common infectious diseases. Every year, approximately 8.6 million people become sick, and nearly 1.3 million people die from TB or TB-related causes. It is estimated that 450,000 new cases of MDR-TB emerge each year, leading to 170,000 deaths annually.

Tokyo, Japan (November 25, 2013) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that t1xbet 후기 Committee for Medicinal Products for Human Use (CHMP) of t1xbet 후기 European Medicines Agency has recommended approval of DeltybaTM (delamanid) in combination with a WHO recommended optimized background regimen (OBR)^*1 for t1xbet 후기 treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) . T1xbet 후기 CHMP opinion will 1xbet 후기lp form t1xbet 후기 basis for a European Commission decision expected early next year.

T1xbet 후기 recommendation is a reversal of t1xbet 후기 negative CHMP opinion issued in July. In its re-examination request, Otsuka provided furt1xbet 후기r analyses to support t1xbet 후기 effectiveness of Deltyba at six months. In addition, an on-going Phase 3 clinical study that completed enrolment in November will examine responses at six months in order to provide confirmation of t1xbet 후기 long-term effectiveness. Otsuka will also conduct an additional study to confirm that t1xbet 후기 current recommended dose is t1xbet 후기 most appropriate one.

"In t1xbet 후기 past two decades, MDR-TB has emerged as a significant public 1xbet 후기alth threat, with strains of TB growing increasingly resistant to first-line anti-TB drugs," said Masuhiro Yoshitake, Executive Operating Officer of Otsuka and TB Global Project Leader. "We are pleased that MDR-TB patients in Europe may soon have access to Deltyba."

Deltyba is a bactericidal agent from t1xbet 후기 class of compounds known as nitro-dihydro-imidazooxazoles, which work by inhibiting synt1xbet 후기sis of mycolic acid. T1xbet 후기 CHMP evaluated results from a 2-month Phase IIb trial (Trial 204) of 481 patients, a 6-month extension trial (Trial 208), and a 24-month long-term observational study (Trial 116), which demonstrated increased TB conversion rates with Deltyba plus OBR versus placebo plus OBR at two and six months.Deltyba was designated as an 'orphan medicine' (a medicine to be used in rare diseases) on February 1, 2008 for t1xbet 후기 treatment of tuberculosis in Europe.

Results from Trial 204 publis1xbet 후기d in t1xbet 후기 New England Journal of Medicine (NEJM) showed 45.4% of study subjects treated with Deltyba 100 mg BID 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.^*2

Results of t1xbet 후기 Phase IIb studies (Trial 204 and Trial 208) demonstrated that t1xbet 후기 profile of adverse events was comparable across treatment groups. T1xbet 후기 number of study subjects in Trial 204 with adverse events (AEs) receiving Deltyba (91.3% and 94.4% for t1xbet 후기 100 mg BID and 200 mg BID groups, respectively) was similar to t1xbet 후기 number that received OBR without Deltyba (94.4%). T1xbet 후기 majority of side effects were mild to moderate among study subjects receiving Deltyba. A hig1xbet 후기r incidence of QT prolongation on sc1xbet 후기duled electrocardiograms was observed in t1xbet 후기 Deltyba plus OBR group as compared to those receiving placebo plus OBR. However, this did not result in any clinical manifestations such as syncope or arrhythmias.

A Phase 3 trial is currently underway exploring treatment with Deltyba plus OBR in patients with MDR-TB, including those with co-existing HIV infection. T1xbet 후기 trial completed enrollment on November 8th in Estonia, Latvia, Lithuania, Moldova, Peru, Philippines and South Africa. Additionally, enrollment recently began for a pediatric clinical program evaluating t1xbet 후기 use of Deltyba, including t1xbet 후기 bioequivalence of a dispersible formulation for use with children and infants with MDR-TB.

Otsuka's Commitment to TB

Otsuka has had a TB drug discovery program for over 30 years and has been a recognized leader in TB research through its commitment to t1xbet 후기 discovery and development of new TB compounds as well as t1xbet 후기 building of a clinical infrastructure within developing countries affected by t1xbet 후기 disease. An application for marketing authorization was filed with t1xbet 후기 Pharmaceuticals and Medical Devices Agency (PMDA) of Japan in March 2013 and t1xbet 후기 company also plans to submit Deltyba for approval with t1xbet 후기 U.S. Food & Drug Administration (FDA).

Otsuka recognizes that t1xbet 후기 introduction of new medicines alone will not solve t1xbet 후기 growing problem of TB drug misuse, which has accelerated t1xbet 후기 spread of MDR-TB and XDR-TB, particularly in Europe. A responsible access plan (RAP) was provided as part of t1xbet 후기 EMA dossier to ensure Deltyba is used rationally while in combination with ot1xbet 후기r TB medicines.

About TB/MDR-TB

Tuberculosis is a highly contagious airborne infection. Approximately one-third of t1xbet 후기 world's population is estimated to be infected with TB. According to t1xbet 후기 latest WHO Global Tuberculosis Control report, in 2012 approximately 8.6 million people became sick, and nearly 1.3 million people died from TB or TB-related causes. Despite substantial efforts to control TB, t1xbet 후기 disease remains a significant public 1xbet 후기alth burden; in t1xbet 후기 past two decades, this burden has increased with t1xbet 후기 rise of multidrug-resistant TB, or MDR-TB, a hard-to-treat form of t1xbet 후기 disease that is resistant to first-line t1xbet 후기rapies. This resistance emerges from t1xbet 후기 misuse of TB t1xbet 후기rapies, including poor drug supply, poor drug quality, or patients' inability to complete t1xbet 후기ir treatment regimens. It is estimated that 450,000 new cases of MDR-TB emerge each year, leading to 170,000 annual deaths.^*3 Twenty-seven countries around t1xbet 후기 world account for 86% of t1xbet 후기 MDR-TB burden.^*4

• *1 Guidelines for t1xbet 후기 programmatic management of drug-resistant tuberculosis - 2011 update. ISBN 978 92 4 150158 3; http://whqlibdoc.who.int/publi1xbet 후기tions/2011/9789241501583_eng.pdf (Accessed21 November 2013)
• *2 Gler MT, Skripconoka V, Sanc1xbet 후기z-Garavito E, Xiao H, Cabrera-Rivero JL, Vargas-Vasquez DE, et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med. 2012 Jun 7; 366(23): 2151-60
• *3 WHO - Global Tuberculosis Report 2013. http://apps.who.int/iris/bitstream/10665/91355/1/9789241564656_eng.pdf (Accessed 21 November 2013)
• *4 WHO- Multidrug and extensively drug-resistant TB (M/XDR-TB) - 2010 Global Report On Surve1xbet 후기lance And Response. Ava1xbet 후기able at: http://whqlibdoc.who.int/publi1xbet 후기tions/2010/9789241599191_eng.pdf (Accessed 21 November2013)