European Medicines Agency supports license to use Xevudy and Kineret to treat COVID-19

The European Medicines Agency (EMA) endorsed the use in the European Union (EU) of two new treatments for COVID-19, the monoclonal antibody sotrovimab (Xevudy) in people over 12 years old and the immunosuppressive drug anakinra (Kineret) in adult patients. .

Xevudy is recommended to treat COVID-19 in adults and adolescents from 12 years of age (and weighing at least 40 kilos), who do not require additional oxygen, but are at increased risk of developing severe COVID-19.

This drug, developed by GlaxoSmithKline Trading Services Limited together with Vir Biotechnology, is already the third monoclonal antibody recommended in the EU to treat COVID-19, after the support received by Regkirona and Ronapreve in November.

Monoclonal antibodies are proteins designed to bind to the SARS-CoV-2 spike protein, which the virus uses to enter human cells.

The Committee for Human Medicines (CHMP) evaluated data from a study involving 1,057 volunteers sick with COVID-19 and showing that Xevudy significantly reduces hospitalizations and deaths in patients with at least one underlying condition that puts them at risk. suffering from severe COVID-19.

According to laboratory studies, Xevudy also works against infections caused by the omicron variant, although most of the patients in the clinical study were infected with other variants of SARS-CoV-2, including the original variant.

Regarding side effects, only a small number of reported hypersensitivity reactions and infusion-related reactions were detected.

While the immunosuppressant Kineret, which is already authorized in the EU as a treatment for various inflammatory conditions, would begin to be indicated to treat COVID-19 in adult patients with pneumonia who require supplemental oxygen and who are at risk of developing severe respiratory failure.

The latter is determined by blood levels of a protein called suPAR (soluble urokinase plasminogen activator receptor) of at least six nanograms per milliliter.

Kineret, marketed by Swedish Orphan Biovitrum AB, reduces the activity of the immune system, which is why it is considered to reduce inflammation associated with COVID-19 and decrease damage to the lower respiratory tract, “preventing the development of severe respiratory failure” .

The CHMP analyzed the results of a study involving 606 adults hospitalized with COVID-19 with moderate or severe pneumonia and who had suPAR levels of at least six nanograms per milliliter, although the standard of care for most included flow oxygen. high or low and the corticosteroid dexamethasone.

“Kineret reduced the risk of a patient’s condition worsening to more serious illness or death during the 28-day study period compared to (who received) the placebo,” adds the EMA.

The efficacy of this drug has not been demonstrated in patients requiring mechanical or non-invasive ventilation or extracorporeal membrane oxygenation.