On 26 March 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Pretomanid FGK*, intended for the treatment of tuberculosis, in combination with bedaquiline and linezolid. The applicant for this medicinal product is FGK Representative Service GmbH.
Pretomanid FGK will be available as 200-mg tablets. The active substance of Pretomanid FGK is pretomanid, an antimycobacterial (ATC code: not yet assigned). Its activity is thought to involve inhibition of the synthesis of cell wall lipids under aerobic conditions and generation of reactive nitrogen species under anaerobic conditions.
The benefits with Pretomanid FGK, given for 6 months with bedaquiline and linezolid, are its ability to produce favourable outcomes in patients with difficult-to treat-infection. The most common side effects noted are peripheral neuropathy, nausea, anemia, vomiting, headache, dyspepsia, acneiform dermatitis, decreased appetite, increased transaminases and gamma glutamyl transpeptidase, rash, pruritus, abdominal pain, musculoskeletal pain and hyperamylasaemia.
The full indication is:
'Pretomanid FGK is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB), see sections 4.2, 4.4 and 5.1.'
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Pretomanid FGK should be started and monitored by physicians experienced in the treatment of tuberculosis.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
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This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
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