FDA approves treatment of patients with new compound Pretomanid drug TB

recently, the non-profit TB Alliance announced that the U.SFood andDrug(http://Administration (
FDA(http://) has approved the new compound Pretomanid for treatment of patients with drug intolerance or non-responsive broadly resistant tuberculosis (XDR-TB) or mDR-TB (MDR-TB)In the United States, the FDA has qualified Pretomanid for priority review,
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s,(QIDP), and orphan drugsPretomanid is expected to be available in the U.Sby the end of the yearPretomanid is also under review by the EuropeanMedicines(http:// Authority (EMA) 　　Pretomanid is a new chemical entity that belongs to a compound called nitromysine The drug has been studied individually or in combination with other anti-TB drugs in 20 clinical
trial (http:// 　　Since TB Alliance began developing pretomanid in 2002, the drug has been clinically tested in 14 countries for more than 1,000 people 　　The study Pretomanid's application for new drug (http:// included data on 1,168 patients who received Pretomanid treatment in 19 clinical trials Phase III clinical study Nix-TB was enrolled in 109 patients with XDR-TB and drug intolerance or non-reactive MDR-TB 　　Data show that 6 months after receiving BPaL treatment and follow-up 6 months after completion of treatment, 95 of the first 107 patients achieved successful treatment, TB sputum culture negative In two cases, the duration of treatment was extended to 9 months 　　In this study, adverse reactions reported included liver toxicity, bone marrow transplantation, and peripheral neuropathy