Drug Update: July 2016 Issue 2

FDA Drug Review News

Advisory Panel to the FDA Votes in Favor of Approval of Two Combination Diabetes Drugs

An advisory panel to the U.S. Food and Drug Administration (FDA) has voted in favor of approval of two new fixed-dose combination diabetes drug, iDegLira® and iGlarLixi®, for the treatment of type 2 diabetes in adults. The FDA is not required to follow the recommendations of the advisory panels but frequently does. If approved, these medications would be the first two products that combine different mechanisms of action for managing blood sugar into single, fixed-dose injections. Read more

Drug Update: July 2016 Issue 1

New Drug Approvals

U.S. Food and Drug Administration (FDA) Approves New Biologic Drug for Multiple Sclerosis

At the end of May, the FDA approved Zinbryta® (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis. Due to the potential for serious side effects, Zinbryta is reserved for patients who have had an inadequate response to two or more other multiple sclerosis drugs. Zinbryta is an immune-modulating monoclonal antibody that is self-administered subcutaneously by the patient once a month.

Multiple sclerosis (MS) is a chronic, autoimmune disease affecting the central nervous system (brain, spinal cord, and eyes). Symptoms of MS may be mild or severe and range from limb numbness to paralysis or vision loss. Disease progression and symptom severity vary substantially across patients, but relapsing MS is the most common form of the disease. Relapsing MS is characterized by acute attacks followed by full recovery or minimal residual problems upon recovery. Read more