The approval of two new treatments for the coronavirus, Xevudy and Kineret, was announced today, Thursday, by the European Medicines Agency (EMA).
Xevudy
In particular, the EMA Human Medicine Committee (CHMP) recommended the approval of the Xevudy monoclonal antibody (sotrovimab) for the treatment of COVID-19. The applicant is GlaxoSmithKline Trading Services Limited, which developed the drug together with Vir Biotechnology.
The Commission has recommended that Xevudy be approved for the treatment of COVID-19 in adults and adolescents (12 years of age and older, at least 40 kg) who do not need supplemental oxygen and are at increased risk of developing the disease.
Xevudy is the third monoclonal antibody treatment recommended in the EU for the treatment of COVID-19 and follows the approval of Regkirona and Ronapreve 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), which the virus uses to enter human cells.
In conclusion, the CHMP evaluated data from a study involving 1,057 patients with COVID-19, which showed that treatment with Xevudy significantly reduced hospitalization and death in patients with at least one underlying condition that puts them at serious risk. COVID-19. After treatment with Xevudy, 1% of patients (6 of 528) were hospitalized for more than 24 hours within 29 days of treatment compared with 6% of patients receiving placebo (30 of 529), 2 of whom they died.
The majority of patients in the study were infected with the original SARS-CoV-2 virus. Some patients became infected with variants such as Alpha and Epsilon. Based on laboratory studies, Xevudy is also expected to be effective against other variants (including Omicron).
Xevudy’s safety profile was favorable, with a small number of hypersensitivity (allergy) and infusion-related reactions, and the CHMP concluded that the benefits of the drug outweighed the risks of approved use.
The CHMP will now send its recommendations to the European Commission for an expedited decision valid in all EU Member States.
While the evaluation of the marketing authorization application was in progress, the committee provided advice to help EU Member States decide on the timely use of this medicine. This means that the drug was already available to some patients in the EU.
Kineret
The EMA’s human drug committee has also recommended extending the Kineret’s indication (anakinra) to include COVID-19 treatment in adult patients with pneumonia who need supplemental oxygen (low- or high-flow oxygen) and who are at risk of developing severe respiratory distress. .
Kineret, marketed by Swedish Orphan Biovitrum AB (publ), is an immunosuppressive drug (meaning it reduces the activity of the immune system). It is currently approved in the EU for the treatment of various inflammatory conditions. In patients with COVID-19, the drug is thought to reduce the inflammation associated with COVID-19 and thus reduce damage to the lower airways, preventing the development of severe respiratory failure.
In conclusion, the CHMP evaluated data from a study of 606 hospitalized adults with moderate to severe COVID-19 pneumonia.
The study showed greater improvement in clinical symptoms in patients treated with Kineret plus standard care compared with those receiving placebo plus standard care. Kineret reduced the risk of worsening a patient’s condition to a more serious illness or death during the 28-day study period compared with placebo. The therapeutic benefit of Kineret compared to placebo was supported by an increase in the number of patients who fully recovered and a decrease in the number of patients whose condition worsened to severe respiratory failure or death.
The study also showed that the safety of Kineret in patients with COVID-19 was similar to that observed in patients treated for the other approved indications. Therefore, the CHMP concluded that the benefits of the drug outweigh the risks to patients such as those studied in this clinical trial. Kineret has not been shown to be effective in patients who require non-invasive or mechanical ventilation or extracorporeal membrane oxygenation (cardiopulmonary bypass life support system).
EMA recommends approval for use of Kineret, an immunosuppressive medicine ????, in #COVID19 adult patients requiring supplemental oxygen and at risk of developing severe respiratory failure.
????https://t.co/Wl6i7Lz6jA pic.twitter.com/qHQdETjeVN— EU Medicines Agency (@EMA_News) December 16, 2021
EMA recommends authorising the #monoclonalantibody Xevudy for the treatment of #COVID19 in adults and adolescents.
????https://t.co/N5Cz0VKkMm pic.twitter.com/mRZtJ55ml4— EU Medicines Agency (@EMA_News) December 16, 2021
Follow Skai.gr on Google News
and be the first to know all the news
.
