Pharmacia & Upjohn has been given the thumbs down for its NNRTI delavirdine (Rescriptor ,TM) by the CPMP, the scientific advisory committee of the European Medicines Evaluation Agency (EMEA). This means that the company will be unable to market the drug in the European Union during 1999, and doctors will be unable to prescribe the drug as first line treatment. The refusal follows evaluation by regulatory agencies in Spain (the `rapporteurs’), and is reported to have hinged on the absence of data demonstrating interactions between delavirdine and protease inhibitors, and the efficacy of the drug in combination with PIs. Pharmacia & Upjohn has been asked to re-submit an application later in 1999 when data is available, and licensing is now thought to be unlikely before the end of 1999.
Delavirdine also fell before regulatory hurdles in the United States. In November 1996 the US Food and Drug Administration’s Antiviral Advisory Committee voted agianst recommending delavirdine for licensing because Pharmacia & Upjohn had not submitted data which demonstrated the performance of delavirdine as part of a triple anti-HIV combination in previously untreated patients. Delavirdine was subsequently licensed in April 1997 after new data became available.
Delavirdine will remain available through a named patient basis scheme in the UK which provides the drug to anyone with a CD4 count below 300 who has failed `currently licensed treatments’. The drug is available through similar schemes in Germany, France.