Pretomanid Approved to Treat Tuberculosis
August 14, 2019 – The U.S. FDA has approved pretomanid, a novel compound developed by the non-profit organization TB Alliance to treat tuberculosis. It is indicated for use in combination with bedaquiline and linezolid to treat adults who have extensively drug-resistant tuberculosis (XDR-TB) or treatment-intolerant or non-responsive multidrug-resistant tuberculosis (MDR-TB).
Tuberculosis is considered one of the world’s deadliest diseases. In 2017, the most recent year for which statistics are available, 9,105 TB cases were reported in the United States, and 1.6 million people worldwide died of the disease. Approximately one-fourth of the world’s population has TB, which is also a leading cause of death in HIV-infected individuals.
According to TB Alliance, the combination of pretomanid with bedaquiline and linezolid (known collectively as the BPaL regimen) offers patients the chance for a shorter, more effective, and more easily managed treatment. Under the current standard of care, patients diagnosed with XDR-TB take up to eight antibiotics for 18 months or more. In the Nix-TB trial, which was conducted across three sites in South Africa, 95 out of 107 patients (89%) experienced treatment success after six months on the BPaL regimen and six months of post-treatment follow up. Recommended dosing is 200mg of pretomanid taken by mouth once per day for 26 weeks.
Pretomanid is the second drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway), which is designed to advance the development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need.
Information on pricing plans is not yet available. Pretomanid is expected to launch in the U.S. by the end of 2019.