Pretomanid, a novel compound developed by the non-profit organization TB Alliance, has been granted conditional marketing authorization by the European Commission (EC) for treating highly drug-resistant forms of pulmonary tuberculosis (TB). According to the press release, the new drug was authorized as part of a three-drug, six month, all-oral regimen for the treatment of adults with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive.
“This regimen provides a new treatment option for patients in the European Union with highly drug-resistant TB infections,” said Mel Spigelman, managing director, president, and chief executive officer of TB Alliance.
The combination treatment of bedaquiline, pretomanid and linezolid – collectively referred to as the BPaL regimen – was studied in the pivotal trial entitled Nix-TB. The multicenter, open-label trial enrolled 109 adults across three sites in South Africa with XDR-TB and treatment-intolerant or non-responsive MDR-TB.
Pretomanid is a new chemical entity and a member of a class of compounds known as nitroimidazooxazines. Developed by TB Alliance since 2002, pretomanid has now received authorization as an oral tablet formulation as part of the BPaL regimen for the treatment of highly drug-resistant forms of pulmonary TB. It is now indicated for use in a limited and specific population of patients.1 The most common side effects noted with the BPaL regimen are peripheral neuropathy, nausea, anemia, vomiting, headache, dyspepsia, acne, decreased appetite, increased transaminases and gamma-glutamyl transpeptidase, rash, pruritus, abdominal pain, musculoskeletal pain and increased amylase.
TB Alliance’s exclusive commercialization partner in Europe is Mylan, a global pharmaceutical company that will market pretomanid as part of the BPaL regimen.
“Mylan has a longstanding commitment to battling infectious diseases around the world. We look forward to bringing Pretomanid to patients throughout Europe and expanding access to this critical treatment as we have done in the US and several rest-of-world markets. The authorization by the European Commission is another step forward in continuing to advance global access to TB treatments for patients in need,” said Mylan president Rajiv Malik.
The conditional authorization requires the completion of a long-term follow-up of patients in the Nix-TB trial and the completion of TB Alliance’s ZeNix trial, which evaluates the safety and efficacy of the BPaL regimen with varying doses and durations of the drug linezolid.
TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners worldwide, the organization aims to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia’s Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Cystic Fibrosis Foundation, European & Developing Countries Clinical Trials Partnership, Germany’s Federal Ministry of Education and Research through KfW, Global Health Innovative Technology Fund, Indonesia Health Fund, Irish Aid, Medical Research Council (United Kingdom), National Institute of Allergy and Infectious Disease, Netherlands Ministry of Foreign Affairs, Rockefeller Foundation, United Kingdom Department for International Development, and the United States Agency for International Development.