01 September 2017 - WHO has just prequalified a two-pills-in-one paediatric medicine that is critical for the continuation phase of the six-month treatment required to cure tuberculosis (TB). The medicine – rifampicin 75mg + isoniazid 50mg – is a fixed dose combination (FDC) tablet manufactured by Macleods Pharmaceuticals Limited. WHO medicines prequalification activities are partly funded by the Bill & Melinda Gates Foundation and by Unitaid.
WHO’s inclusion of the medicine in its Prequalification list means that the product has been found to meet international standards of quality, safety and efficacy. It is available for procurement through the Global Drug Facility, which supports TB medicines procurement for United Nations programmes, international procurement agencies as well as national procurement entities.
“The listing of this product is very good news,” said Dr Mario Raviglione, Director of the Global TB Programme at WHO. “Lack of adequate child-friendly medicines to treat TB has been a huge problem for a long time. The fact that we now have the medicines and they meet WHO quality standards is expected to rapidly expand access to effective treatment for children all over the world.”
The prequalified double FDC is preceded, for the first few weeks of treatment, by another product – rifampicin 75mg + isoniazid 50mg + pyrazinamide 150mg. That product is currently under review by the Prequalification team. Both FDCs were included in the WHO Model List of Essential Medicines for children, in May 2017.
The child-friendly FDCs were developed in line with new WHO guidelines (Guidance for national tuberculosis programmes on the management of tuberculosis in children), which revised the medicine’s dosing to achieve appropriate therapeutic levels for children. They are water-dispersible tablets and have a pleasant taste. They offer the opportunity to simplify and improve treatment for children around the world and are therefore likely to enhance adherence and completion of treatment, as well as to prevent the development of drug resistance.
The child-friendly TB fixed-dose combinations have been developed with support from Unitaid through the STEP-TB project. The project was implemented by the Global Alliance for TB Drug Development (TB Alliance) in close collaboration with WHO.