FDA APPROVES PRETOMANID REGISTRATION IN THE
PHILIPPINES
The Philippine Food and Drug Administration (FDA) officially approved the Certificate of Product Registration (CPR) of Pretomanid (Pa) on 6 September 2022 paving the way for greater accessibility and availability of the Pa-containing regimens.
In May 2022, WHO issued a Rapid Communication stating that all patients with MDR/RR-TB, including those with additional resistance to fluoroquinolones, stand to benefit from effective all-oral treatment regimens implemented under programmatic conditions.
Pretomanid was approved by the US FDA on 14 Aug 2019 as part of a combination regimen with Bedaquiline and Linezolid (BPaL) for adults with pulmonary XDR-TB, treatment-intolerant and treatment non-responsive MDR-/RR-TB. The 2020 WHO Consolidated guidelines for Drug-resistant TB recommended the BPaL regimen under operational research (OR). The Philippines is among the countries currently implementing the BPaL regimen under OR in 12 sites through the LIFT-TB initiative of TB Alliance, in collaboration with the International Tuberculosis Research Center and KNCV.
The application for Pa registration in the country was facilitated by Faberco/SMHP Marketing and Consultancy, the local Pa distributor (Dovprela ®) with the collaborative support from the Procurement and Supply Chain Advisor of the DOH-Disease Prevention and Control Bureau, the Tropical Disease Foundation and LIFT-TB.
The FDA approval represents a major milestone in the fight against highly resistant TB in the Philippines as Pa-containing regimens will soon be available programmatically to provide shorter, highly effective and more manageable treatment giving hope for cure to affected populations.