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FDA Approves Sirturo for Multi-Drug Resistant Tuberculosis

First drug to treat multi-drug resistant tuberculosis On Dec. 28, the U.S. Food and Drug Administration approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available. TB is an infection caused by Mycobacterium tuberculosis and is one of the world’s deadliest diseases. It is spread from person to person through the air and usually affects the lungs, but it can also affect other parts of the body such as the brain and kidneys. According to the Centers for Disease Control and Prevention, nearly 9 million people around the world and 10,528 people in the United States became sick with TB in 2011. Multi-drug resistant TB occurs when M. tuberculosis becomes resistant to isonazid and rifampin, two powerful drugs most commonly used to treat TB. Sirturo is the first drug approved to treat multi-drug resistant TB and should be used in combination with other drugs used to treat TB. Sirturo works by inhibiting an enzyme needed by M. tuberculosis to replicate and spread throughout the body. “Multi-drug resistant tuberculosis poses a serious health threat throughout the world, and Sirturo provides much-needed treatment for patients who have don’t have other therapeutic options available,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don’t have other treatment options.” Sirturo is being approved under the FDA’s accelerated approval program, which allows the agency to approve a...

Addressing the Antibiotic Resistance Crisis

Antibiotic-resistant infections cost the healthcare system more than $20 billion annually and result in more than 8 million additional days in the hospital. Overcoming the crisis will require comprehensive, multipronged strategies that are aimed at reducing the emergence and spread of antimicrobial-resistant organisms. Few New Antibiotics on the Horizon Many pharmaceutical companies have had less interest in developing new antibiotics because they aren’t as profitable as drugs used to treat chronic conditions or lifestyle issues. Additional barriers include uncertainties about requirements for FDA approval and the scientific and technical challenges that are inherent in identifying new classes of antibiotics. Once a successful new antibiotic clears hurdles and enters the market, the profitability of the drug is limited by effective antimicrobial stewardship programs and by the ability of microbes to rapidly adapt to antibiotics. Since 2008, only two new antibiotics have been approved by the FDA. “As much as 50% of antibiotic use in humans is either unnecessary or inappropriate.” The Infectious Diseases Society of America set forth the 10 x ‘20 Initiative to spur the development of 10 new antibiotics by 2020, a goal that includes new incentives for drug research and development, among other strategies. Unfortunately, little progress has been made in achieving this goal. Accordingly, legislators need to support new incentives for industry, and regulators need to consider the important clinical and public health benefits that antibiotics provide as they develop new guidelines and update existing guidance for the design of clinical trials. Education on Antibiotic Use is Critical As much as 50% of antibiotic use in humans is either unnecessary or inappropriate. Efforts to increase education...
Assessing Options for Pneumonia Hospitalizations

Assessing Options for Pneumonia Hospitalizations

Community-acquired pneumonia (CAP) affects approximately 4 million patients in the United States each year. Around 20% of these patients are admitted to hospitals for treatment. In patients requiring inpatient treatment, overall mortality is approximately 12%. However, it can be much higher in CAP patients requiring admission to the ICU. When parenteral antimicrobials are required for the treatment of hospitalized patients, the mainstay of therapy for many years has included either a combination of a β-lactam antibiotic with a macrolide antibiotic, or the use of a respiratory fluoroquinolone alone. β-lactam antibiotics do not have antibacterial activity against the so-called “atypical bacteria,” including species of Mycoplasma, Chlamydia, andLegionella, which are important pathogens in CAP. Classes of antibiotics active against these atypical pathogens include macrolides, fluoroquinolones, and tetracyclines. Urgent Need of New Antimicrobial Agents Two important realities are beginning to impact the traditional recommendations for antimicrobial therapy in CAP. First, there is an urgent need for the development of new antimicrobial agents that are more active against resistant bacterial pathogens. Second, the rapid development of antimicrobial-resistant bacterial pathogens has compromised many of our existing antimicrobials. “Antimicrobial resistance continues to increase in a dramatic fashion.” While there are many reasons for the slowing of new antimicrobial discoveries and the rapid development of antimicrobial resistance, the major factors appear to be overuse and misuse of antibiotics in both man and animals and the inability of the pharmaceutical industry to realize significant financial return on investment from new antimicrobial development. This lack of new agents has been called one of the three greatest threats to human health by the Infectious Diseases Society of America (IDSA). Yet, antimicrobial...
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