FDA approves new drugs for the treatment of tuberculosis, a form of lung resistance

The U.S. Food and Drug Administration today approved Pretomanid pills in a joint use with bedaquilin and linazine for the treatment of a particular type of highly drug-resistant tuberculosis.
“ The threat of antimicrobial-resistant infections is a major challenge for us as a public health organization," said Dr. Amy Abernethy, FDA's chief deputy commissioner. MDR-TB and MDR-TB are public health threats due to limited treatment options. New treatments are important to meet the patient's national and global health needs. That's why in our other efforts to address antimicrobial resistance, we focus on promoting the development of safe and effective new therapies that give patients more options to fight life-threatening infections. The approval also marks the second time the drug has been approved in a limited population pathway for antimicrobial and antificial drugs, a pathway proposed by Congress to promote the development of drugs for infections that lack effective therapies. We hope to continue to see more development of antimicrobial drugs for severe or life-threatening infections in a limited population with unlimited medical needs.approved the use of Pretomanid drugs in partnership with bedaquilin and linazine for the treatment of a limited and specific group of adult patients with broad resistance to multidrive or non-reactive tuberculosis. MDR-TB and MDR-TB are difficult to treat due to drug resistance to existing therapies. According to the World Health Organization, there were an estimated 490,000 new cases of MDR-TB worldwide in 2016, of which the more drug-resistant cases were smaller.
A study of 109 patients with extensive drug resistance, treatment of non-reactive or non-reactive multidramine tuberculosis (lungs) demonstrated the safety and importance of Pretomanid, which is taken in the mouth in the same way as bedaquilin and linazine. Of the 107 patients assessed six months after treatment, 95 (89%) were successful, significantly exceeding the historical success rate of extensive drug-resistant TB treatment.
The most common adverse reactions observed in patients treated with Pretomanid in a joint treatment with Bedaquilin and lynazine included nerve damage (peripheral neuropathy), acne, anemia, nausea, vomiting, headache, liver enzymes (transaminase and γ-glutamine transferase), indigestion (indigestion), rash, elevated trypsin (hyperamylaseemia), vision impairment, hypoglycemia and diarrhea. Pretomanid, which is used in a combined form with bedaquilin and linazine, should not be used in patients who are allergic to bedaquilin or linazine.
Pretomanid is the second drug approved by Congress under the Limited Population Antimicrobial and Antificial Drug Pathway (lpad Pathway) established by the 21st Century Treatment Act to promote the development and approval of antimicrobial and antificial drugs to treat serious or life-threatening infections under the LPAD pathway, which can be supported by simplified clinical development programs. These programs may involve smaller, shorter, or fewer clinical trials. Pretomanid's label includes certain statements indicating that the drug has been shown to be safe and effective only in a limited number of people, in accordance with the requirements of the LPAD pathway approved drug.
Pretomanid also received the FDA's Qualified Infectious Disease Products (QIDP) title.
QIDP is designated as an antibacterial and antificial drug product designed to treat serious or life-threatening infections under the FDA's Immediate Antibiotic Incentives (GAIN) Act.According to the FDA's approval of the Pretomanid Pill Priority Review, the FDA's goal is to take action on applications within an expedited time period and to approve the designation of orphan drugs, which provides incentives to assist and encourage the development of drugs for rare diseases. （cyy123.com）