Schering-Plough Corporation reported that the US FDA has accepted for review its New Drug Application (NDA) for posaconazole oral suspension. The review provides for FDA action within 10 months from the date of receipt of the NDA. The NDA was submitted to FDA in May 2004.
Schering-Plough is seeking marketing approval of posaconazole for the treatment of invasive fungal infections (e.g., aspergillosis, fusariosis, zygomycosis) in patients with refractory disease or who are intolerant to other therapy, the company release says.
Schering-Plough plans to file a similar new drug application for posaconazole with the European Medicines Agency (EMEA).
Development of posaconazole is consistent with Schering-Plough's strategy to broaden its anti-infective portfolio and is in line with its plans to build strength in its global franchises through both internal research and external licensing opportunities.
Posaconazole is a novel triazole agent, discovered and developed by Schering-Plough Research Institute that exhibits potent antifungal activity in vitro against a wide range of fungal pathogens, including both yeasts and molds. This new chemical entity is being developed for the treatment of invasive fungal infections, which most often occur in severely immuno-compromised patients, such as organ transplant patients or cancer patients undergoing chemotherapy. Posaconazole provides an oral therapy option for these serious infections caused by a variety of fungal organisms, including those resistant to other drugs.