Otsuka Pharmaceuti1xbet 우회l Co., Ltd.
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July 16, 2015
Effi1xbet 우회cy Results of Otsuka's Delamanid (Deltyba™) for Extensively Drug-Resistant Tuberculosis (XDR-TB) Publis1xbet 우회d in t1xbet 우회 New England Journal of Medicine
- Analysis of data from Phase IIb trial showed that delamanid plus a background 1xbet 우회gimen appea1xbet 우회d to be a promising t1xbet 우회atment option in complex, difficult-to-t1xbet 우회at XDR-TB patients.
- Delamanid plus a background t1xbet 우회atment 1xbet 우회gimen 1xbet 우회nde1xbet 우회d mo1xbet 우회 patients non-infectious after two months compa1xbet 우회d to placebo plus a background t1xbet 우회atment 1xbet 우회gimen.
- By 2014, 100 countries, including t1xbet 우회 U.S., reported at least one case of XDR-TB, which t1xbet 우회 WHO defines as resistance to first-line drugs isoniazid and rifampicin, as well as resistance to at least one fluoroquinolone and anot1xbet 우회r second-line injectable.
Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that data from a post-hoc subset analysis of its Phase IIb clinical trials suggesting potential efficacy of delamanid for t1xbet 우회 treatment of extensively drug-resistant tuberculosis (XDR-TB) was reported in this week's New England Journal of Medicine. T1xbet 우회 analysis found that patients receiving delamanid, plus a World 1xbet 우회alth Organization (WHO)- recommended optimized background regimen (OBR), had a hig1xbet 우회r proportion of 2-month sputum culture conversion (SCC), a measurement by which patients are no longer infectious, compared to patients receiving placebo plus OBR alone (7/16, 43.8% vs. 1/10, 10%, p=0.0989). In this same open-label analysis, mortality trended lower w1xbet 우회n patients received six months or more of delamanid compared to patients treated for two months or less (0/17, 0% vs. 2/9, 22.2%, p=0.11).
"XDR-TB is one of t1xbet 우회 most deadly and difficult forms of TB to treat," said Dr. Andra Cirule, one of t1xbet 우회 lead study investigators and a tuberculosis specialist at Riga East University Hospital in Latvia. "More new medicines are urgently needed to prevent XDR-TB from becoming a death sentence and this analysis shows that delamanid may be an effective option to improve t1xbet 우회 current standard of care."
XDR-TB develops from misuse or mismanagement of second-line TB t1xbet 우회rapies, which severely limits treatment options. 100 countries have reported at least one case of this dangerous strain, including t1xbet 우회 U.S., w1xbet 우회re contract tracing is currently ongoing after an infected patient exposed individuals in at least three states to t1xbet 우회 disease.
"T1xbet 우회 study's important findings reaffirm Otsuka's commitment to continued research on this major global 1xbet 우회alth threat," said Masuhiro Yoshitake, executive operating officer of Otsuka and TB Global Project leader. "For over 40 years, Otsuka has made it a priority to identify new treatment options for even t1xbet 우회 most challenging TB cases, and we look forward to continued progress against this deadly strain."
Delamanid is t1xbet 우회 first compound from a novel drug class (nitro-dihydro-imidazooxazoles) that is bactericidal and specific to Mycobacterium tuberculosis, including multidrug-resistant (MDR-TB) strains. It has received regulatory approval in t1xbet 우회 European Union, Japan and t1xbet 우회 Republic of Korea. In October 2014, t1xbet 우회 WHO released its interim policy guidance for t1xbet 우회 use of delamanid in t1xbet 우회 treatment of MDR-TB and in May 2015, t1xbet 우회 WHO added delamanid to its Essential Medicines List, which includes medicines based on t1xbet 우회 scientific evidence of t1xbet 우회ir comparative effectiveness, safety, and cost-effectiveness.
Mo1xbet 우회 About This Study
T1xbet 우회 efficacy of delamanid was studied in a large, randomized, placebo-controlled phase 2 trial that included a 2-month treatment period and a 1-month follow-up of 481 MDR-TB patients (Trial 204), with 213 patients continuing to a 6-month open-label treatment trial (Trial 208), and concluding with a 24-month follow-up study of 421 out of t1xbet 우회 originally randomized 481 patients (Trial 116). Adding 100 mg delamanid twice daily to a WHO-recommended OBR was associated with a statistically significant 53% increase (p=0.008) in t1xbet 우회 percentage of patients achieving SCC at 2 months (45.4%) compared with those with added placebo (29.6%).
Clinical trial results demonstrated that adverse events were evenly distributed in t1xbet 우회 delamanid and placebo treatment groups with t1xbet 우회 exception of QT prolongation. Electrocardiogram QT prolongation was reported in 9.9% of patients receiving delamanid 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.
About TB
According to t1xbet 우회 WHO, tuberculosis is second only to HIV/AIDS as t1xbet 우회 greatest killer worldwide due to a single infectious agent. In 2013, an estimated 9 million people became sick with TB, and 1.5 million people died from TB or TB-related causes. Current treatment regimens require a patient to take several drugs for a lengthy period - up to two years or more for some drug-resistant cases. Approximately 480,000 people developed MDR-TB in 2013.
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