FDA Actions

FDA Actions

The FDA has approved afibercept for the treatment of diabetic retinopathy in patients with diabetic macular edema. It is the second drug to be approved for this indication this year after ranibizumab (Lucentis). Alfibercept is an inhibitor or vascular endothelial growth factor. The drug is injected into the eye once a month for 5 months then once every 2 months. Approval was based on two studies of 679 patients who were randomized to afibercept or macular laser photocoagulation. At week 100, afibercept patients showed significant improvement in their diabetic retinopathy compared to patients who did not receive the injections. The drug was approved with breakthrough therapy designation. It was previously approved for the treatment of wet age-related macular degeneration and diabetic macular edema secondary to retinal vein occlusion. Alfibercept is marketed by Regeneron Pharmaceuticals as Eylea.

The FDA has added a new warning to the label of the smoking deterrent drug varenicline (Chantix) regarding potential adverse reactions with alcohol. The FDA reports that there have been almost 50 adverse events reported with the drug involving alcohol since the drug was approved in 2006. These events include increased intoxicating effects of alcohol sometimes associated with aggressive behavior and/or amnesia. There also have been more than 60 cases of seizures, mostly occurring in patients without seizure history. The drug also has a black box warning regarding neuropsychiatric changes. With this new warning, the FDA recommends weighing the potential risk of seizures against the potential benefit, and also recommends cutting back on alcohol intake when initiating the medication (www.FDA.gov/Safety/MedWatch/).

The FDA has approved isavuconazonium sulfate, a new azole antifungal for the treatment of adults with invasive aspergillosis and invasive mucormycosis. The drug is available in oral and intravenous formulations. It was approved as a “Qualified Infectious Disease Product,” the sixth such improved antibacterial or antifungal to receive this designation. Approval was based on a clinical trial of more than 500 patients randomly assigned to receive isavuconazonium or voriconazole, which showed equivalent outcomes and safety. Isavuconazonium is marketed by Astellas Pharma as Cresemba.