Pretomanid tablets in combination with bedaquiline and linezolid have been approved for the treatment of a highly treatment-resistant type of pulmonary tuberculosis (TB), the U.S. Food and Drug Administration announced today.
The treatment combination was approved to treat adult patients with extensively drug-resistant, treatment-intolerant, or nonresponsive multidrug-resistant pulmonary TB. Dosing involves 200 mg of Pretomanid tablets orally once daily for 26 weeks, 400 mg of bedaquiline orally once daily for two weeks followed by 200 mg three times per week for 24 weeks, and 1,200 mg of oral linezolid daily for up to 26 weeks.
Researchers evaluated the safety and effectiveness of Pretomanid taken in combination with bedaquiline and linezolid in a study of 107 patients with extensively drug-resistant, treatment-intolerant, or nonresponsive multidrug-resistant pulmonary TB. At six months posttherapy, 89 percent of patients were successfully treated, which according to the FDA, exceeds the historical success rates for extensively drug-resistant TB.
The most commonly reported adverse reactions included peripheral neuropathy, acne, anemia, nausea, vomiting, headache, elevated transaminases and gamma-glutamyltransferase, dyspepsia, rash, hyperamylasemia, visual impairment, hypoglycemia, and diarrhea.
The drug combination of Pretomanid and bedaquiline and linezolid should not be used in patients with hypersensitivity to bedaquiline or linezolid or those with drug-resistant tuberculosis, latent infection or extrapulmonary infection due to Mycobacterium tuberculosis, or multidrug TB that is not treatment-intolerant or nonresponsive to standard therapy.
Approval was granted to The Global Alliance for TB Drug Development.