The European pharmaceutical licensing authority's scientific advisory board has rejected licensing applications for the Glaxo-Wellcome protease inhibitor amprenavir and the Pharmacia & Upjohn NNRTI delavirdine.
Amprenavir will be reviewed again in six months time after the results of salvage therapy studies are available. The committee was not prepared to license amprenavir for first-line therapy because of its poor performance when tested head to head against indinavir in treatment-naive individuals, and because insufficient data is available on its use as a second-line protease inhibitor in people who have failed currently licensed PIs.
Delavirdine was withdrawn from consideration by its manufacturer Pharmacia & Upjohn after members of the CPMP made it clear that the company had provided them with insufficient data about delavirdine's interactions with protease inhibitors. The company was also unable to prove that delavirdine, a three times daily drug, offers any added benefits compared with the NRRTIs already licensed, efavirenz and nevirapine, in terms of side effect profile, efficacy or dosing schedule.
The delay means that amprenavir is unlikely to be launched in Europe until the last quarter of 2000, more than a year and half after its US launch. The decisions also signal that European licensing authorities intend to take a much tougher line on drugs which are not products in a new class, and that future protease inhibitors, NNRTIs and NRTIs will have to demonstrate that they offer valuable additions to the range of drugs already licensed.
Expanded access arrangements for delavirdine will be taken over by Agouron/Warner-Lambert, Joy Schmitt of Agouron told aidsmap this week. The company plans to evaluate delavirdine in combination with protease inhibitors and with NNRTIs before attempting to gain a license for the drug in Europe.