Briefing Summary: US FDA Posts Advisory Committee Materials to Review Risk Management of Alexion’s Soliris (Eculizumab) – NOV 18, 2014 (DSRM)
The US FDA has posted details, including company and FDA Briefing Materials, for the Tuesday, November 18, 2014 Drug Safety and Risk Management Advisory Committee (DSRM) Meeting. The FDA Amendments Act of 2007 requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) before the DSRM. Accordingly, the Agency will seek public input whether the REMS with ETASU for this drug assures safe use of the drug, is not unduly burdensome on patient access to the drug, and to the extent practicable, minimizes the burden on the health care delivery system.
SOLIRIS is a complement inhibitor indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.