What is Enzepi - Daclizumab and what is it used for?
Medicinal product withdrawn from the marketZinbryta is a medicine used to treat adults with relapsing forms of multiple sclerosis. Multiple sclerosis is a disease in which inflammation damages the protective layer surrounding nerve cells in the brain and spinal cord. Relapsing means that the patient has flare-ups of symptoms.
Zinbryta contains the active substance daclizumab
How is Enzepi used?
Zinbryta can only be obtained with a prescription and treatment should be started by a doctor experienced in the management of multiple sclerosis. The recommended dose is 150 mg injected subcutaneously once a month. Patients should be instructed to inject themselves using either a pre-filled syringe or an injection pen device. See the package leaflet for further information.
How does Enzepi - Daclizumab work?
In multiple sclerosis, the body's immune system (defenses) mistakenly attacks and damages the protective layer surrounding the nerve cells of the central nervous system (the brain and spinal cord). The active substance in Zinbryta, daclizumab, is a monoclonal antibody. which attacks T lymphocytes. These cells are part of the body's immune system and are activated by interleukin-2, a signaling protein in the body. By attacking T lymphocytes, daclizumab blocks interleukin-2, thereby preventing T lymphocytes from attacking and damaging nerve cells. Daclizumab may also have other effects that reduce the damaging effects of the immune system on nerve cells.
What benefit has Enzepi - Daclizumab shown during the studies?
Zinbryta was effective in treating relapsing multiple sclerosis in two main studies involving more than 2,400 patients.
In a study involving 600 patients, Zinbryta was shown to be more effective than placebo (a dummy treatment) in reducing disease recurrence. Patients treated with Zinbryta 150 mg every 4 weeks had an average of 0.21 relapses in one year compared with 0.46 for those receiving placebo.
In another study with 1,841 patients, patients treated with Zinbryta at a dose of 150 mg every 4 weeks had an average of 0.22 relapses in one year compared with 0.39 for those receiving interferon beta-1a, another medicine. used for multiple sclerosis.
What are the risks associated with Enzepi - Daclizumab?
The most common side effects with Zinbryta (which may affect more than 1 in 100 people) are rash, increased liver enzymes in the blood, depression, inflammation and pain in the nose and throat, flu and upper respiratory tract infections such as colds and lymphadenopathy (enlarged glands). The most common serious side effects of Zinbryta are liver damage and severe skin reactions. For the full list of restrictions and side effects reported with Zinbryta, see the package leaflet.
Why has Enzepi - Daclizumab been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zinbryta's benefits are greater than its risks and recommended that it be approved for use in the EU. Zinbryta was found to be effective in studies conducted for periods up to at 3 years. Zinbryta works differently than existing treatments and has the advantage of being given only once a month. The treatment is associated with several side effects on the liver and an increased risk of infections but the CHMP considered these risks can be managed with regular control.
What measures are being taken to ensure the safe and effective use of Enzepi - Daclizumab?
The company that markets Zinbryta will provide educational material to healthcare professionals and patients about liver damage and how to prevent or reduce such damage.
Recommendations and precautions for the safe and effective use of Zinbryta by healthcare professionals and patients have also been included in the summary of product characteristics and package leaflet.
More information about Enzepi - Daclizumab
For the full version of the Zinbryta EPAR, please consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Zinbryta therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The information on Enzepi - Daclizumab published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
