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, 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 more information on the mechanism of action of daclizumab check Gavin’s post ~6 months ago. Personally, I am concerned about yet another drug with a potentially significant secondary autoimmunity problem, however the EMA was happy with daclizumab’s risk:benefit profile.