Split Verdict From Panel On P&U's Delavirdine

US Food and Drug Administration advisory panel members were unable to reach a decision at their meeting late last month over whether Pharmacia & Upjohn's AIDS drug Rescriptor (delavirdine) should be recommended for approval.

Noting that the drug's activity against HIV and the clinical improvement in patients were small, and also that delavirdine failed to offer any benefit for patients in the late stages of the disease, the panel was split 4-4 on the recommendation. Delavirdine is a non-nucleoside reverse transcriptase inhibitor, in the same class as Boehringer Ingelheim's Viramune (nevirapine), which was launched in its first market, the USA, a couple of months ago (Marketletter September 2).

P&U maintains that the drug was effective in reducing the viral load and boosting CD4 counts in early-stage patients, when it is given alongside nucleoside analog drugs. A 720-patient study comparing delavirdine plus Glaxo Wellcome's Retrovir (zidovudine) versus zidovudine alone found that patients in early-stage disease exhibited a slight rise in CD4 cell counts on the combination, while the reduction in viral load was twice that seen in patients given zidovudine alone.