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EMA Panel Backs Daclizumab (Zinbryta) for Multiple Sclerosis
Megan Brooks | Disclosures
April 29, 2016
The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for daclizumab (Zinbryta, Biogen Idec) for the treatment of adults with relapsing forms of multiple sclerosis (RMS).
Daclizumab is given by self-administered subcutaneous injection once a month.
The humanized monoclonal antibody selectively binds to the high-affinity interleukin-2 receptor subunit (CD25) expressed at abnormally high levels on T cells in patients with MS. Daclizumab offers a targeted mechanism of action that does not cause broad and prolonged immune cell depletion, the company notes in a news release.
According to the CHMP opinion, the benefits of daclizumab include its ability to reduce the annualized relapse rate and risk for disability progression.
The positive CHMP opinion is based on results from two clinical trials. In the DECIDE study, reported previously by Medscape Medical News, daclizumab 150 mg administered subcutaneously every 4 weeks showed a reduced relapse rate and fewer new lesions on MRI compared with interferon β-1a (Avonex, Biogen) injected intramuscularly weekly.
In the placebo-controlled SELECT study, daclizumab reduced relapse rates and had positive effects on key measures of MS disease activity relative to placebo.
The most common side effects with daclizumab seen in clinical trials are elevations of liver enzymes and hepatic injury, cutaneous events, infections, gastrointestinal disorders, and depression. The CHMP recommends that daclizumab be prescribed by physicians experienced in the management of MS.
"For people with relapsing forms of MS (RMS) and active disease, Zinbryta has the potential to offer robust efficacy, a manageable safety profile through patient monitoring, and once-monthly subcutaneous dosing," Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen, said in the release.
Detailed recommendations for the use of daclizumab will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the European Commission grants marketing authorization.
Daclizumab is also under regulatory review in the United States, Switzerland, Canada, and Australia.
Megan Brooks | Disclosures
April 29, 2016
The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for daclizumab (Zinbryta, Biogen Idec) for the treatment of adults with relapsing forms of multiple sclerosis (RMS).
Daclizumab is given by self-administered subcutaneous injection once a month.
The humanized monoclonal antibody selectively binds to the high-affinity interleukin-2 receptor subunit (CD25) expressed at abnormally high levels on T cells in patients with MS. Daclizumab offers a targeted mechanism of action that does not cause broad and prolonged immune cell depletion, the company notes in a news release.
According to the CHMP opinion, the benefits of daclizumab include its ability to reduce the annualized relapse rate and risk for disability progression.
The positive CHMP opinion is based on results from two clinical trials. In the DECIDE study, reported previously by Medscape Medical News, daclizumab 150 mg administered subcutaneously every 4 weeks showed a reduced relapse rate and fewer new lesions on MRI compared with interferon β-1a (Avonex, Biogen) injected intramuscularly weekly.
In the placebo-controlled SELECT study, daclizumab reduced relapse rates and had positive effects on key measures of MS disease activity relative to placebo.
The most common side effects with daclizumab seen in clinical trials are elevations of liver enzymes and hepatic injury, cutaneous events, infections, gastrointestinal disorders, and depression. The CHMP recommends that daclizumab be prescribed by physicians experienced in the management of MS.
"For people with relapsing forms of MS (RMS) and active disease, Zinbryta has the potential to offer robust efficacy, a manageable safety profile through patient monitoring, and once-monthly subcutaneous dosing," Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen, said in the release.
Detailed recommendations for the use of daclizumab will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the European Commission grants marketing authorization.
Daclizumab is also under regulatory review in the United States, Switzerland, Canada, and Australia.
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