The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has recommended approval of pretomanid FGK (FGK Representative Service GmbH) for drug-resistant tuberculosis (TB).
Pretomanid FGK is an antimicrobial indicated for use in combination with bedaquiline and linezolid for adults with extensively drug-resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) TB. It will be available as 200-mg tablets.
Pretomanid FGK, taken orally for 6 months with bedaquiline and linezolid, has been shown to produce favorable outcomes in patients with "difficult-to-treat infection," the EMA said in a statement.
The most common side effects are peripheral neuropathy, nausea, anemia, vomiting, headache, dyspepsia, acneiform dermatitis, decreased appetite, increased transaminase and gamma glutamyl transpeptidase levels, rash, pruritus, abdominal pain, musculoskeletal pain, and hyperamylasemia.
Pretomanid FGK should be started and monitored by physicians experienced in the treatment of TB, the EMA said.
Detailed recommendations for the use of pretomanid FGK will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.
"A Game Changer"
The US Food and Drug Administration (FDA) approved pretomanid, in combination with bedaquiline and linezolid, for drug-resistant TB in August 2019, as reported by Medscape Medical News.
The safety and effectiveness of the pretomanid with bedaquiline and linezolid was demonstrated in a study of 109 patients with XDR, treatment-intolerant, or nonresponsive MDR-TB. The treatment was successful in 95 (89%) of the 107 patients who were evaluated 6 months after the end of therapy. The success rate far exceeded those of available treatments, the FDA said in a news release announcing its approval.
In speaking with Medscape Medical News at the time, Amita Gupta, MD, deputy director of the Johns Hopkins University Center for Clinical Global Health Education in Baltimore, Maryland, called pretomanid a "game changer for these highly resistant patients."
Cite this: EMA Panel Backs Pretomanid for Drug-Resistant TB - Medscape - Mar 31, 2020.