Pfizer Vfend for acute aspergillosis
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pfizer's antifungal Vfend (voriconazole) should be approved for treatment of acute invasive aspergillosis, FDA's Antiviral Drugs Advisory Committee unanimously agrees Oct. 4. The group voted 8-2 against approval of an indication for empiric therapy in all febrile neutropenic patients, saying use should be limited to immunocompromised febrile patients who have undergone an allogenic bone marrow transplant or had relapsed leukemia. Pfizer is also seeking indications for voriconazole for treatment of Candida infections, infections caused by Scedosporium and Fusarium, and rare and refractory infections. Those indications were not discussed during the meeting
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.