百佳乐官方网站-百佳乐手机版下载

FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs

2019/8/15 9:33:30 source:FDA Author: Print

 The U.S. Food and Drug Administration today approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs.

 
“The threat of antimicrobial-resistant infections is a key challenge we face as a public health agency,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “The bacterium that causes tuberculosis can develop resistance to the antibiotics used to treat it. Multidrug-resistant TB and extensively drug-resistant TB are public health threats due to limited treatment options. New treatments are important to meet patient national and global health needs. That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections. This approval also marks the second time a drug is being approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, a pathway, advanced by Congress, to spur development of drugs targeting infections that lack effective therapies. We hope we continue to see more development of antibacterial drugs for treating serious or life-threatening infections in limited populations of patients with unmet medical needs.”
 
Pretomanid in combination with bedaquiline and linezolid is approved for treating a limited and specific population of adult patients with extensively drug resistant, treatment-intolerant or nonresponsive multidrug resistant pulmonary TB. Multidrug-resistant TB and extensively drug-resistant TB are difficult to treat due to resistance to available therapies. According to the World Health Organization, in 2016, there were an estimated 490,000 new cases of multidrug-resistant TB worldwide, with a smaller portion of cases of extensively drug-resistant TB.
 
The safety and effectiveness of Pretomanid, taken orally in combination with bedaquiline and linezolid, was primarily demonstrated in a study of 109 patients with extensively drug-resistant, treatment intolerant or non-responsive multidrug-resistant pulmonary TB (of the lungs). Of the 107 patients who were evaluated six months after the end of therapy, 95 (89%) were successes, which significantly exceeded the historical success rates for treatment of extensively drug resistant TB.
 
The most common adverse reactions observed in patients treated with Pretomanid in combination with bedaquiline and linezolid included damage to the nerves (peripheral neuropathy), acne, anemia, nausea, vomiting, headache, increased liver enzymes (transaminases and gamma-glutamyltransferase), indigestion (dyspepsia), rash, increased pancreatic enzymes (hyperamylasemia), visual impairment, low blood sugar (hypoglycemia), and diarrhea.
 
Pretomanid used in combination with bedaquiline and linezolid should not be used in patients with hypersensitivity to bedaquiline or linezolid.
 
Pretomanid is the second drug to be approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD pathway, established by Congress under the 21st Century Cures Act to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need. Approval under the LPAD pathway may be supported by a streamlined clinical development program. These programs may involve smaller, shorter or fewer clinical trials. As required for drugs approved under the LPAD pathway, labeling for Pretomanid includes certain statements to convey that the drug has been shown to be safe and effective only for use in a limited population.
 
Pretomanid also received the FDA’s Qualified Infectious Disease Product (QIDP) designation. The QIDP designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.
 
The FDA granted Pretomanid Tablets Priority Review, under which the FDA’s goal is to take action on an application within an expedited time frame, and Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
 
The FDA granted the approval of Pretomanid Tablets to The Global Alliance for TB Drug Development (TB Alliance). With this approval, The Global Alliance for TB Drug Development is awarded a Tropical Disease Priority Review Voucher in accordance with a provision included in the Food and Drug Administration Amendments Act of 2007 that aims to encourage development of new drugs and biological products for the prevention and treatment of certain tropical diseases.
 

Government agencyLocal learningHospital websiteIndustry media

WORLD HEALTH ORGANIZATION CHINA ASSOCIATION FOR SCIENCE AND TECHNOLOGY DEVELOPMENT RESEARCH CENTER OF THE STATE COUNCIL OF THE PEOPLE'S REPUBLIC OF CHINA CHINESE ACADEMY OF ENGINEERING CHINESE SOCIAL SCIENCES NET CHINESE ACADEMY OF SCIENCES NATIONAL HEALTH COMMISSION OF THE PEOPLE'S REPUBLIC OF CHINA THE STATE COUNCIL OF THE PEOPLE'S REPUBLIC OF CHINA MINISTRY OF SCIENCE AND TECHNOLOGY OF THE PEOPLE'S REPUBLIC OF CHINA MINISTRY OF COMMERCE OF THE PEOPLE'S REPUBLIC OF CHINA
GANSU PHARMACEUTICAL ASSOCIATION NINGXIA HUI AOTONOMOUS REGION PHARMACEUTICAL SOCIETY SICHUAN PHARMACEUTICAL ASSOCIATION GUANGDONG PHARMACEUTICAL ASSOCIATION SHANDONG PHARMACEUTICAL ASSOCIATION ZHEJIANG PHARMACEUTICAL ASSOCIATION BEIJING PHARMACEUTICAL ASSOCIATION HEBEI PHARMACEUTICAL ASSOCIATION
BEIJING FRIENDSHIP HOSPITAL, CAPITAL MEDICAL UNIVERSITY CHINA-JAPAN FRIENDSHIP HOSPITAL BEIJING HOSPITAL BEIJING TONGREN HOSPITAL, CMU BEIJING JISHUITAN HOSPITAL BEIJING ANZHEN HOSPITAL, CAPITAL MEDICAL UNIVERSITY BEIJING CHAO-YANG HOSPITAL BEIJING TIAN TAN HOSPITAL, CAPITAL MEDICAL UNIVERSITY BEIJING DITAN HOSPITAL CAPITAL MEDICAL UNIVERSITY XUANWU HOSPITAL CAPITAL MEDICAL UNIVERSITY BEIJING SHIJITAN HOSPITAL BEIJING YOUAN HOSPITAL BEIJING OBSTETRICS AND GYNECOLOGY HOSPITAL BEIJING CHILDREN'S HOSPITAL CAPITAL INSTITUTE OF PEDIATRICS CHINESE PLA GENERAL HOSPITAL
MEDICINE.CHINA.COM.CN HEALTH.SOHU.COM JIANKANGBAO XINHUANET EN.PEOPLE.CN
XML 地图 | Sitemap 地图