The U.S. Food and Drug Administration on Wednesday approved a new Tuberculosis medicine called Pretomanid for the treatment of hard-to-treat tuberculosis which affects the lungs.
The Pretomanid tablets is to be used in combination with two other existing medicine; bedaquiline and linezolid.
Hard-to-treat infections referred to as Antimicrobial-resistant infections is a public health threat which remains a key challenge to global health. The germ 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 imperative to meet patient national and global health 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.
The new combo could help over 75,000 patients per year, mostly in India, China, Indonesia, South Africa and Nigeria.
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.
Developing the Pretomanid medicine
According to the US FDA, 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.
Side effects of Pretomanid medicine
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.
First TB drug from a nonprofit group
The FDA granted the approval of Pretomanid Tablets to The Global Alliance for TB Drug Development (TB Alliance) thus making it the first TB drug from a nonprofit group, the 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.