The European Medicines Agency recommends further restrictions on the use of Daliju monoantigen

The European Medicines Agency (EADA) on October 27th published the results of an assessment of the liver safety of Daliju monoantigen, recommending further restrictions on the use of the drug.
the European Medicines Agency, the Drug Alert Risk Assessment Committee determined that the drug could cause immuno-mediated damage to the patient's liver during the use of the drug and within six months of its suspension.
July 2016 in the European Union for the treatment of adult multiple sclerosis. Liver damage was a known risk when the EU approved the listing of Daliju monolithic, and the EU has recommended a number of measures to control this risk, including requiring regular testing of liver function and providing medical personnel and patients with educational materials on the risk of liver damage.
The Drug Alert Risk Assessment Committee recommends that doctors use the drug only if patients with multiple sclerosis are less likely to respond to at least two treatments that improve their condition and are unable to accept other treatments that improve their condition, and recommends that they test the patient's liver function at least once a month, or before each medication, and continue to regularly test for liver function for 6 months after discontinuation.
the European Medicines Agency said the recommendations would be submitted to the Human Medicines Commission, which would approve the final opinion. The proposals will then be extended to EU member states after approval by the European Commission.
is a monoclonal antibody drug (referred to as monoantigen). The high specificity, effectiveness and low toxicity of these drugs have changed the course of treatment for cancer and autoimmune diseases, resulting in a significant improvement in the survival or quality of life of patients. Monoantic drug development has become one of the fastest growing biopharmaceuticals in recent years, with the birth of several heavyweight drugs with sales of more than $5 billion. (Xinhuanet)