FDA Panel Unanimously Backs Approval of Pfizer Antifungal Drug
An FDA panel on Thursday expressed unanimous support for the approval of Vfend, Pfizer Inc.'s new antifungal drug used to treat serious fungal infections, the Wall Street Journal reports. Some fungal infections can be fatal in those whose immune systems have been compromised from AIDS, cancer or organ transplants. In Pfizer studies, 71% of those on Vfend were still alive after 84 days versus 58% of those on amphotericin B, a "common" antifungal treatment. After 12 weeks, 53% of patients on Vfend were "successfully treated" compared to 32% of those on the other medication. However, because fungal infections often occur in conjunction with other potentially fatal diseases, the exact causes of patients' deaths were difficult to ascertain. The FDA is likely to approve the drug for sale in the United States based on the panel's recommendation, according to the Journal (Wall Street Journal, 10/5).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.