CHMP recommends approval for Pretomanid FGK, intended for the treatment of tuberculosis, in combination with bedaquiline and linezolid.- TB Alliance

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.