FDA News Briefs for Wednesday, November 21, 2018November 21, 2018
These Food and Drug Administration (FDA) developments came in this week:
FDA Approves Gamifant for Primary Hemophagocytic Lymphohistiocytosis
On November 20, 2018, the FDA approved Gamifant (emapalumab-lzsg; Novimmune) for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease, or intolerance with conventional HLH therapy. Gamifant is an intravenously administered fully human monoclonal antibody that is a potent inhibitor of interferon-gamma, a cytokine secreted by cells of the immune system to help regulate immune functions. More Information.
FDA Safety Alert: Gilenya
The FDA issued a safety communication warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod; Novartis) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This worsening is rare, but can result in permanent disability. As a result, the FDA has added a new warning about this risk to the prescribing information of the Gilenya drug label and patient Medication Guide. More Information.
Recall: Beckman Coulter Flow Cytometers
Beckman Coulter Life Sciences is recalling the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers due to an electrical circuit error that may cause the device’s amplifier board to malfunction and produce inaccurate results. This issue has the potential to impact all tests run on the cytometers for any application, including laboratory-developed tests. No patient injuries have been reported to date, however the use of an affected product may cause serious, life-threatening adverse health consequences such as misdiagnosis and improper patient management and treatment for several blood conditions and diseases. More Information.