EU medicines agency recommends Xevudy, Kineret for Covid treatment
The European Medicines Agency (EMA) on Thursday recommended the use of Kineret and Xevudy for the treatment of coronavirus disease (Covid-19).
EMA’s human medicines committee recommended the use of Kineret in adult Covid-19 patients with pneumonia requiring supplemental oxygen and who are at risk of developing severe respiratory failure.
Kineret, an immunosuppressive medicine, reduces the activity of the immune system and is currently used by the EU member countries for the treatment of various inflammatory conditions.
“In Covid-19 patients, the medicine is considered to reduce the inflammation associated with Covid-19 and thus decrease lower airway damage, preventing development of severe respiratory failure,” the medicines agency said in a statement.
The committee recommended authorising Kineret after evaluating data from a study that involved 606 hospitalised adults with moderate or severe Covid. In addition to ‘standard of care’, these patients were administered Kineret or placebo by injection under the skin. Standard of care includes the use of low or high flow oxygen and the corticosteroid medicine dexamethasone, with some also receiving remdesivir.
EMA said the study showed greater clinical symptom improvements in patients treated with Kineret plus standard of care compared with those who received placebo plus standard of care.
The committee also recommended the approval of Xevudy for treating the disease in adults and adolescents who do not require supplemental oxygen but are at increased risk of the disease becoming severe. Xevudy is the third monoclonal antibody to be recommended for Covid treatment in the EU.
The committee evaluated data from a study involving 1,057 Covid-19 patients with at least one underlying condition, putting them at increased risk of severe Covid. The study showed that Xevudy significantly reduced hospitalisation and deaths, with 1% of patients being hospitalised for longer than 24 hours within 29 days of treatment with the monoclonal antibody, compared with 6% of patients on placebo.