EU APPLICATIONS FOR AMPHOCIL COMPLETE

Liposome Technology and Zeneca Pharmaceuticals have submitted marketing authorization applications for the liposomal amphotericin B antifungal Amphocil in Finland, Sweden and the 10 European Union countries where filing has not already taken place (all except the UK, where it is approved, and Ireland, where it is pending approval).

The product is indicated for the treatment of severe systemic fungal infections in patients for whom conventional amphotericin B is contraindicated due to toxicity or renal failure, or where previous therapy has failed. Zeneca will market the drug in EU countries as well as most international areas, excluding the USA, Canada and Japan and some selected small markets where LTI has agents.

The drug is currently in Phase III trials for the treatment of systemic fungal infections in patients who have failed amphotericin B therapy, in patients with underlying kidney malfunction and in patients with disseminated fungal infections. The Phase III trials, notes LTI, are designed to provide the basis for a New Drug Application to be filed with the US Food and Drug Administration.