The approval of two new drugs for the treatment of COVID-19 is recommended by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (Coreper).
According to the announcement, these are the Xevudy monoclonal antibody (sotrovimab) developed by GlaxoSmithKline in collaboration with Vir Biotechnology, and the Swedish immunosuppressive drug Kineret (anakinra) by Swedish Orphan Biovitrum.
Xevudy is intended for the treatment of COVID-19 for adults and children over 12 (over 40 kg) who do not need extra oxygen and are not at increased risk for serious coronavirus disease.
Kineret is already licensed in the EU for the treatment of various inflammatory diseases. EMA approval applies to its use in the treatment of patients with pneumonia who require additional oxygen (low or high flow) at risk of developing severe respiratory failure as determined by the presence of at least 6 ng per ml of suPAR (soluble plasminogen activator receptor) protein. urokinase).
In particular, Xevudy is the third monoclonal antibody to be used against COVID-19 in the EU after Regkirona and Ronapreve, which were approved in November. Monoclonal antibodies are proteins designed to attach to a specific target, in this case the SARS-CoV-2 spike protein (the virus that causes COVID-19) so that the virus cannot enter the body’s cells.
The CHMP evaluated data from a study of 1057 patients with COVID-19, which found that treatment with Xevudy significantly reduced hospitalizations and deaths of patients with underlying diseases. Specifically, only 1% of patients who received the drug (6 out of 528) had to be hospitalized for more than 24 hours during their 29 days of treatment, compared with 6% of patients who received placebo (30 of 529). ), two of whom died.
Most patients in the study were infected with the original SARS-CoV-2 virus while some were infected with variants, including Alpha and Epsilon. According to laboratory results, the drug is expected to be active against other variants, including Omicron.
The drug was considered safe, with only a few cases of hypersensitivity (allergy) and infusion-related reactions. The CHMP ruled that the benefits of the drug outweighed the risks of approved use.
Kineret is thought to reduce COVID-19-induced inflammation by reducing damage to the lower airways and preventing the development of severe respiratory failure.
The CHMP based its findings on a study of 606 adults treated for moderate to severe pneumonia as a result of COVID-19 with suPAR levels of at least 6 ng per ml.
Patients received either Kineret or placebo by injection, in addition to the treatment they were already receiving. The study showed a greater improvement in the symptoms of patients receiving Kineret plus conventional therapy than those receiving placebo plus conventional therapy.