Drug Update: August 2016 Issue 2

Specialty Update

Advisory Panel to the FDA Votes in Favor of Approval of New Psoriasis Medication

In July, an advisory panel to the U.S. Food and Drug Administration (FDA) voted in favor of a new monoclonal antibody, brodalumab, for the treatment of plaque psoriasis. The recommendation in favor of approval was contingent on the manufacturer, Valeant Pharmaceuticals, 1) implementing a risk-management plan to mitigate the potential suicide risk and 2) labeling the medication that it may be associated with a higher risk of suicide. Six suicides were observed during the clinical trials. However panel members found it difficult to determine if brodalumab was linked to an increased risk of suicide as patients with psoriasis are in general more likely to experience anxiety, depression, and suicidal ideation. Read more

Drug Update: August 2016 Issue 1

New Drug Approvals

U.S. Food and Drug Administration (FDA) Approves New Medication for Dry Eye Disease

Last month, the FDA approved a first-in-class agent for the treatment of dry eye disease, Xiidra® 5% (lifitegrast ophthalmic solution). Xiidra is a twice-daily eye drop solution indicated for the treatment of signs and symptoms of dry eye disease in adults and is the first medication in a new drug class called lymphocyte function-associated antigen 1 (LFA-1) antagonists. Xiidra will be supplied as a 5% solution in single-use containers.

Dry eye disease is a chronic condition that affects an estimated 16 million people in the United States. The condition occurs when production of tears is insufficient or if tear consistency is abnormal. It is associated with inflammation that may damage the surface of the eye if serious and left untreated. Patients with dry eye disease may experience eye discomfort, dryness, stinging, burning, a gritty feeling, or visual disturbances. The exact mechanism of action of Xiidra in dry eye disease is not known, however Xiidra binds to the integrin LFA-1 receptor found on leukocytes. This binding blocks the interaction of LFA-1 with ICAM-1 (intracellular adhesion molecule-1), thereby preventing the activation and migration of inflammatory T-cells. Read more