WHO Prequalification Unit - Medicines Assessment Team (PQT/MED) has been in contact with Sanofi regarding the presence of 1-cyclopentyl-4-nitrosopiperazine (CPNP) in their tuberculosis treatment - Priftin (rifapentine). PQT/MED prequalified this medicine as TB336, based on SRA approval. In this instance, prequalification was based upon the registration of this product with the USFDA. As per USFDAs notification dated 29 October 2020, USFDA will not object to the temporary distribution of rifapentine containing CPNP below 20 ppm. PQT/MED recognises the USFDA decision for this product. Sanofi is providing regular updates to PQT/MED on this matter.
Please refer to our previous note regarding rifapentine and rifampicin in: https://extranet.who.int/pqweb/news/nitrosamine-concerns-rifapentine-and-rifampicin
PQT/MED continues to assess the information on nitrosamine impurities and their associated risk.