Weigh! US regulators strongly support the approval of a new generation of macrolide antibiotics by cempra

November 8, 2016 / BIOON / -- FDA's Advisory Committee on antimicrobial drugs approved the result that the benefits of sulithromycin, a new antibiotic of cempra, outweighed the risks in the treatment process by 7 votes to 6 votes Members of the Advisory Committee agreed that solithromycin was effective in the treatment of community acquired bacterial pneumonia (CaBP), and there was not sufficient evidence to prove that solithromycin can cause the risk of hepatotoxicity Prabhavathi, President and CEO of cempra Fernandes commented in the group discussion that these favorable opinions and in-depth comments on the correct use of antibiotics coincide with cempra's commitment We are committed to using solithromycin in the right patients, and taking 5-7 days as a course of oral or intravenous injection of macrolides as a single therapy for CaBP In the United States alone, pneumonia has become the leading cause of death, and the use of macrolides in the treatment of CaBP has produced more than 50% of pneumococcal resistance We believe that solithromycin has great potential in treatment and can provide patients and doctors with a new treatment option At the same time, we also hope to continue to strengthen cooperation with FDA to complete the review as soon as possible According to the clinical trial data released by cempra last year, compared with the traditional macrolide antibiotic moxifloxacin, the early clinical response (72 hours) of solithromycin, a new generation of macrolide antibiotic, showed statistically non inferiority In addition, the safety of sulithromycin and moxifloxacin was similar The most common adverse reactions were headache (4.5% and 2.5%), diarrhea (4.2% and 6.5%), nausea (3.5% and 3.9%), vomiting (2.4% and 2.3%) and dizziness (2.1% and 1.6%) Although FDA is not bound by the Advisory Committee, it often uses the Advisory Committee's advice for reference when evaluating clinical experimental drugs Cempra points out that if sulithromycin is approved for marketing, sulithromycin will become the first new generation of macrolide antibiotics for oral and intravenous injection in more than 20 years This article is the original compilation of Biovalley, welcome to reprint! Click for authorization For more information, please download the Biovalley app Original source: US regulatory panel backs cempra's new antiviral