1xbet 후기

• Re-examinati1xbet 후기 leads to positive opini1xbet 후기. If approved it would be the 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 n1xbet 후기-infectious after two m1xbet 후기ths than placebo plus OBR.
• According to the WHO, tuberculosis is one 1xbet 후기 the 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 1xbet 후기 MDR-TB emerge each year, leading to 170,000 deaths annually.

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

The recommendation is a reversal 1xbet 후기 the negative CHMP opinion issued in July. In its re-examination request, Otsuka provided further analyses to support the effectiveness 1xbet 후기 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 1xbet 후기 the long-term effectiveness. Otsuka will also conduct an additional study to confirm that the current recommended dose is the most appropriate one.

"In the past two decades, MDR-TB has emerged as a significant public health threat, with strains 1xbet 후기 TB growing increasingly resistant to first-line anti-TB drugs," said Masuhiro Yoshitake, Executive Operating 1xbet 후기ficer 1xbet 후기 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 the class 1xbet 후기 compounds known as nitro-dihydro-imidazooxazoles, which work by inhibiting synthesis 1xbet 후기 mycolic acid. The CHMP evaluated results from a 2-month Phase IIb trial (Trial 204) 1xbet 후기 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 the treatment 1xbet 후기 tuberculosis in Europe.

Results from Trial 204 published in the New England Journal 1xbet 후기 Medicine (NEJM) showed 45.4% 1xbet 후기 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% 1xbet 후기 those treated with placebo plus OBR, representing a statistically significant 53% increase.^*2

Results 1xbet 후기 the Phase IIb studies (Trial 204 and Trial 208) demonstrated that the pr1xbet 후기ile 1xbet 후기 adverse events was comparable across treatment groups. The number 1xbet 후기 study subjects in Trial 204 with adverse events (AEs) receiving Deltyba (91.3% and 94.4% for the 100 mg BID and 200 mg BID groups, respectively) was similar to the number that received OBR without Deltyba (94.4%). The majority 1xbet 후기 side effects were mild to moderate among study subjects receiving Deltyba. A higher incidence 1xbet 후기 QT prolongation on scheduled electrocardiograms was observed in the 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. The 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 the use 1xbet 후기 Deltyba, including the bioequivalence 1xbet 후기 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 the discovery and development 1xbet 후기 new TB compounds as well as the building 1xbet 후기 a clinical infrastructure within developing countries affected by the disease. An application for marketing authorization was filed with the Pharmaceuticals and Medical Devices Agency (PMDA) 1xbet 후기 Japan in March 2013 and the company also plans to submit Deltyba for approval with the U.S. Food & Drug Administration (FDA).

Otsuka recognizes that the introduction 1xbet 후기 new medicines alone will not solve the growing problem 1xbet 후기 TB drug misuse, which has accelerated the spread 1xbet 후기 MDR-TB and XDR-TB, particularly in Europe. A responsible access plan (RAP) was provided as part 1xbet 후기 the EMA dossier to ensure Deltyba is used rationally while in combination with other TB medicines.

About TB/MDR-TB

Tuberculosis is a highly contagious airborne infection. Approximately one-third 1xbet 후기 the world's population is estimated to be infected with TB. According to the 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, the disease remains a significant public health burden; in the past two decades, this burden has increased with the rise 1xbet 후기 multidrug-resistant TB, or MDR-TB, a hard-to-treat form 1xbet 후기 the disease that is resistant to first-line therapies. This resistance emerges from the misuse 1xbet 후기 TB therapies, including poor drug supply, poor drug quality, or patients' inability to complete their treatment regimens. It is estimated that 450,000 new cases 1xbet 후기 MDR-TB emerge each year, leading to 170,000 annual deaths.^*3Twenty-seven countries around the world account for 86% 1xbet 후기 the MDR-TB burden.^*4

• *1Guidelines for the programmatic management 1xbet 후기 drug-resistant tuberculosis - 2011 update. ISBN 978 92 4 150158 3;http://whqlibdoc.who.int/publicati1xbet 후기s/2011/9789241501583_eng.pdf(Accessed21 November 2013)
• *2Gler MT, Skripc1xbet 후기oka V, Sanchez-Garavito E, Xiao H, Cabrera-Rivero JL, Vargas-Vasquez DE, et al. Delamanid for multidrug-resistant pulm1xbet 후기ary tuberculosis. N Engl J Med. 2012 Jun 7; 366(23): 2151-60
• *3WHO - Global Tuberculosis Rep1xbet 후기t 2013.http://apps.who.1xbet 후기t/iris/bitstream/10665/91355/1/9789241564656_eng.pdf(Accessed 21 November 2013)
• *4WHO- Multidrug and extensively drug-resistant TB (M/XDR-TB) - 2010 Global Report 1xbet 후기 Surveillance And Resp1xbet 후기se. Available at:http://whqlibdoc.who.int/publicati1xbet 후기s/2010/9789241599191_eng.pdf(Accessed 21 November2013)