UK drugmaker York Pharma says it has begun to prepare for the launch of Abasol (abafungin), a topical treatment for fungal infections of the skin, in the first half of next year.
York has just received feedback from the regulatory authorities in the UK, the first country to review the marketing application for Abasol. While the Medicines and Healthcare products Regulatory Agency (MHRA) has asked for more data to supplement the dossier, the company said it was “confident that [its] response will be submitted shortly and of achieving its commercial launch in first-half 2007.”
Following registration of Abasol in the UK, which is the first country to review the new product, York will seek approvals in other European markets through the mutual recognition procedure.
Abafungin is a novel broad-spectrum antifungal agent with a new mechanism of action that both inhibits fungal cell membrane formation and disrupts the integrity of existing membranes. The compound has been shown to have fungicidal and fungistatic effects on a wide variety of pathogens, including dermatophytes, yeasts (including Candida) and moulds.