Schering-Plough's Posaconazole Receives FDA Review for Invasive Fungal Infections

Strategic Insights -

The U.S. Food and Drug Administration (FDA) has accepted for review Schering-Plough's New Drug Application (NDA) for posaconazole oral suspension, potentially providing a new treatment option for severely immunocompromised patients with invasive fungal infections. The review process is expected to conclude within 10 months from the date of receipt of the NDA. The NDA was submitted in May 2004 for posaconazole, a novel triazole agent with potent antifungal activity against a wide range of fungal pathogens.

Key Takeaways:

  • Schering-Plough's NDA for posaconazole oral suspension has been accepted for review by the FDA for the treatment of invasive fungal infections, such as aspergillosis, fusariosis, and zygomycosis.
  • The FDA review is expected to conclude within 10 months from the date of receipt of the NDA, which was submitted in May 2004.
  • Posaconazole is a novel triazole agent with potent antifungal activity against a wide range of fungal pathogens, including yeasts and molds.
  • The new drug is being developed for the treatment of severe fungal infections in immunocompromised patients, such as organ transplant patients or cancer patients undergoing chemotherapy.
  • 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 build strength in its global franchises through internal research and external licensing opportunities.
  • Schering-Plough is a global science-based health care company with leading prescription, consumer, and animal health products.

Statistics:

  • The FDA review process is expected to conclude within 10 months after the date of receipt of the NDA.
  • The NDA for posaconazole oral suspension was submitted in May 2004.
  • Posaconazole exhibits potent antifungal activity against a wide range of fungal pathogens, including yeasts and molds.
  • Invasive fungal infections, such as aspergillosis, fusariosis, and zygomycosis, are often treated with older therapies that may have limited efficacy or cause side effects.
  • Schering-Plough has a global research organization with over 30,000 people across the world.

Sources:

  • Schering-Plough Corporation (Source: "Schering-Plough Files New Drug Application for Posaconazole for Invasive Fungal Infections" released on May 20, 2004).
  • PR Newswire (Source: Company News On-Call: http://www.prnewswire.com/comp/777050.html).