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FDA Gives Nod to Daclizumab (Zinbryta) for Multiple Sclerosis

Treatment may cause severe liver injury

The FDA has approved daclizumab (Zinbryta, Biogen) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Daclizumab is a long-acting injection that is self-administered by the patient on a monthly basis.

The efficacy of daclizumab was demonstrated in two clinical studies. One study compared daclizumab and Avonex (interferon beta-1a, Biogen) in 1,841 patients who were treated for 144 weeks. The patients receiving daclizumab had fewer clinical relapses than the patients taking Avonex. The second study compared daclizumab with placebo in 412 patients who were treated for 52 weeks. In that study, the patients receiving daclizumab had fewer relapses compared with those given placebo.

Daclizumab should generally be used only in patients who have had an inadequate response to two or more MS drugs because it has serious safety risks, including liver injury and immune conditions. Because of these risks, the labeling for daclizumab includes a boxed warning, and the treatment 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 before starting daclizumab; monthly before each dose; and for up to six months after the last dose.

The boxed warning also highlights other important risks of daclizumab treatment, including immune conditions, such as noninfectious colitis, skin reactions, and lymphadenopathy. Additional highlighted warnings include anaphylaxis or angioedema, an increased risk of infections, and symptoms of depression and/or suicidal ideation.

The most common adverse events reported by patients treated with daclizumab in the clinical study that compared daclizumab with Avonex included nasopharyngitis, upper respiratory tract infection, rash, influenza, dermatitis, oropharyngeal pain, eczema, and enlargement of lymph nodes. The most common adverse events reported by patients treated with daclizumab when compared with placebo included depression, rash, and increased alanine aminotransferase.

MS 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 in men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to a progressive decline in function and increased disability. Most people experience their first symptoms of MS between the ages of 20 and 40.

Source: FDA; May 27, 2016.

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