Johnson and Johnson TB new drug Situro gets EU conditional approval

Business, March 10 (JNJ) announced on March 7 that the new tuberculosis drug Situro (bedaquiline) has been granted conditional approval by the European Commission (EC) as part of a combination therapy for patients with mDR-TB whose treatment is not available for treatment because of drug resistance or tolerancepreviously, Sirturo was designated as an orphan drug and was approved by the EU CHMP in December 2013CHMP believes that the data provided by Johnson and Johnson show that Sirturo's clinical benefits outweigh its risks, and that the drug may help address the medical needs of MDR-TB that are far from being met in new treatment options, but the data are not yet comprehensive and more research should be done on the use of Sirturoin the United States, Sirturo was approved by the FDA in December 2012 through an accelerated approval process, the first TB drug in nearly 40 years with a new mechanism of action and the first TB drug ever explicitly used for MDR-TBSirturo has a unique mechanism of action to kill Mycobacterium tuberculosis (M.tb) by targeting ATP synthases, which are essential for energy productionSirturo's approval is based on 24-week data for a Phase II clinical development projectUnder the rules, Johnson and Johnson will conduct a Phase III trial to further confirm Sirturo's risk of interest and determine its optimal use, including the type of drug required for combination, the quantity and the optimal duration of treatmenttuberculosis is an infectiousdisease
caused by Mycobacterium tuberculosis, which affects the lungsTuberculosis is a rare disease in the Eu, where the incidence rate is estimated at 2.3 per 10,000, according to 2011 projectionsMDR-TB is tb, which is at least resistant to isoniazid and rifampicin, two of the main anti-TB drugs used in the standardtreatment of TBGlobally, there are estimated to be about 450,000 MDR-TB cases per year, equivalent to 5 per cent of TB globally each yearin recent years, the problem of publichealth caused by drug-resistant TB has increased rapidly due to the lack of new treatment options MDR-TB, which is associated with high mortality rates, poses a serious public health threat because patients infected with drug-resistant strains do not receive adequate treatment and may spread the infection Sirturo offers hope for patients who have no other treatment option However, there are some serious risks to the drug, and doctors should ensure that the drug is used reasonably and only in patients who are not effective for other anti-TB treatments