The European Medicines Agency (EMA) has started a review of medicines containing the antibiotic fosfomycin, following a request from the German medicines regulatory agency.
The agency highlighted how interest in fosfomycin has undergone a revival in recent years because of its unique mode of action and a unique chemical structure that make cross-resistance uncommon and allow for addictive and synergistic activities with other antibiotics. It says, however, there are limited data comparing the efficacy of fosfomycin to standard regimens.
The German regulator also says that there are significant differences in the product information for fosfomycin products across European Member States and the wording of some indications is too broad. The agency says there is a need to reevaluate the benefit-risk balance of the approved indications for these products considering current scientific knowledge. Furthermore, it says, the appropriate dose and duration of administration for oral, intravenous and intramuscular formulations needs to be addressed, as well as the adequacy of safety-relevant information.
The review is being undertaken by the EMA’s Committee for Medicinal Products for Human Use (CHMP) and will determine if the licences for these products should be maintained, altered, suspended or revoked.