Drugs Xagena
The FDA ( Food and Drug Administration ) has approved Zinbryta ( Daclizumab ) for the treatment of adults with relapsing forms of multiple sclerosis. Zinbryta is a long-acting injection that is self- administered by the patient monthly.
Multiple sclerosis is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with multiple sclerosis, episodes of worsening function ( relapses ) are initially followed by recovery periods ( remissions ). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Most people experience their first symptoms of multiple sclerosis between the ages of 20 and 40.
The effectiveness of Zinbryta was shown in two clinical trials. One trial compared Zinbryta and Avonex ( Interferon beta-1a ) in 1,841 participants who were studied for 144 weeks. Patients on Zinbryta had fewer clinical relapses than patients taking Avonex.
The second trial compared Zinbryta with placebo and included 412 participants who were treated for 52 weeks. In that study, those receiving Zinbryta had fewer relapses compared to those receiving placebo.
Zinbryta should generally be used only in patients who have had an inadequate response to two or more multiple sclerosis drugs because Zinbryta has serious safety risks, including liver injury and immune conditions. Because of the risks, Zinbryta has a boxed warning and is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy ( REMS ).
The boxed warning tells prescribers that the drug can cause severe liver injury, including life-threatening and fatal events. Health care professionals should perform blood tests to monitor the patient’s liver function prior to starting Zinbryta, monthly before each dose, and for up to six months after the last dose.
The boxed warning also highlights other important risks of Zinbryta treatment including immune conditions, such as inflammation of the colon ( non-infectious colitis ), skin reactions, and enlargement of lymph nodes ( lymphadenopathy ).
Additional highlighted warnings include hypersensitivity reactions ( anaphylaxis or angioedema ), increased risk of infections, and symptoms of depression and/or suicidal ideation.
The most common adverse reactions reported by patients receiving Zinbryta in the clinical trial that compared it to Avonex include cold symptoms ( nasopharyngitis ), upper respiratory tract infection, rash, influenza, dermatitis, throat ( oropharyngeal ) pain, eczema, and enlargement of lymph nodes.
The most common adverse reactions reported by patients receiving Zinbryta when compared to placebo are depression, rash, and increased alanine aminotransferase. ( Xagena )
Source: FDA, 2016
XagenaMedicine_2016
