NOV 18 DSRM

The US FDA has scheduled a Drug Safety and Risk Management Advisory Committee (DSRM) Meeting for Tuesday, November 18, 2014 to discuss the risk management of Alexion Pharmaceuticals Inc.’s eculizumab (SOLIRIS). 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.

As part of the REMS, physicians who prescribe eculizumab (SOLIRIS) must agree to educate patients on the risks and benefits of treatment and to provide patients a copy of the FDA-approved Medication Guide at each infusion. Physicians must also report to the Sponsor or the FDA (serious life-threatening) cases of meningococcal infection, including the patients’ clinical outcomes.

See the SAC Tracker Report