Xevudy (sotrovimab) is a drug that has just been authorized by the Haute Autorité de Santé (HAS) in France for the treatment of Covid-19. What are its indications? Its effectiveness once morest the Omicron variant of Covid-19? Its side effects?
In one notice published on January 7, 2022, the Haute Autorité de Santé (HAS) has granted an authorization for early post-Marketing Authorization (marketing authorization) to the drug Xevudy (sotrovimab) in the indication of “treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with severe coronavirus 2019 (Covid-19) that do not require oxygen supplementation and are at risk of developing into severe Covid-19“. What are the exact indications for this treatment? Is it effective once morest variant Omicron du Covid-19 ? What are its side effects?
Definition: What is the Xevudy treatment?
Xevudy is a curative treatment for Covid-19 with the active substance sotrovimab, a antibody monoclonal. It is a drug reserved for a hospital use. This treatment is administered by intravenous infusion in the hospital. Each vial contains 500mg of sotrovimab in 8mL of solution. The other ingredients are: histidine, histidine monohydrochloride, sucrose, polysorbate 80, methionine and water for injections. “To date, it is the only treatment with monoclonal antibodies authorized in curative and whose neutralizing activity should be retained once morest the Omicron variant“, according to the National Agency for the Safety of Medicines and Health Products (ANSM).
What are the indications in France?
The Haute Autorité de Santé (HAS) has granted a post-marketing authorization for early access (marketing authorization) to the drug Xevudy (sotrovimab) from the laboratory GlaxoSmithKline (GSK) in the indication of “treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with 2019 coronavirus disease (Covid-19) that do not require oxygen supplementation and are at risk of developing into severe Covid-19“namely the following populations as defined by the ANRS-Emerging Infectious Diseases:
- Patients 80 years of age and over;
- Patients with an immunity deficit linked to a pathology or to treatments:
- Chemotherapy in progress,
- Solid organ transplantation,
- Allogeneic hematopoietic stem cell transplantation,
- Systemic or vascular lupus with immunosuppressive treatment,
- Corticosteroid treatment> 10 mg / day of prednisone equivalent for more than 2 weeks,
- Immunosuppressive therapy including rituximab;
- Patients at risk of complications:
- Obese (BMI> 30 kg / m²),
- COPD and respiratory failure chronic,
- Complicated high blood pressure,
- Heart failure,
- Diabetes (type 1 and type 2),
- Chronic renal failure,
- Other chronic pathologies
This authorization is valid for a period of 12 months from the date of notification and may be renewed under the conditions provided for in Article R. 5121-69-4 of the Public Health Code. Xevudy had obtained marketing authorization forEuropean Medicines Agency (EMA) on December 17, 2021. HAS recalls that Xevudy does not exempt patients from complying with barrier and physical distancing measures and that this medicine is not intended to be used as a substitute for vaccination once morest Covid-19.
How effective once morest Covid-19 and the Omicron variant?
The active substance Sotrovimab is a monoclonal antibody entirely of human origin which has a double action: a neutralizing action in preventing the virus from infecting new cells and a powerful effector in eliminating already infested cells. “This monoclonal antibody presents a mechanism of action which makes it possible to hope that it will maintain its effectiveness on the variants, including the variant omicron“underlines the HAS. According to studies relayed by the HAS, Xevudy would reduce the risk of progression to a severe form of Covid-19 (hospitalization for more than 24 hours or death) d‘regarding 80% (COMET-ICE study) following administration of the treatment.
What are the side effects ?
“The allergic reactions in Xevudy are common, and may affect up to 1 in 10 people“Says the European Medicines Agency (EMA). Side effects are: rash or redness, itching, difficulty breathing, feeling dizzy. Finally, the infusion for the administration of Xevudy carries the risk of side effects : redness, chills, fever, difficulty in breathing, rapid heartbeat, drop in blood pressure.
What is the dosage?
“The recommended dose for adults and adolescents (aged 12 years and over and weighing at least 40 kg) is 500mg (one vial) administered intravenously in a healthcare facility where patients can be monitored during administration and for at least 1 hour following administration“, indicates the HAS. It is recommended toadminister within 5 days of onset of symptoms of Covid-19“specifies the HAS.
Which laboratory markets Xevudy?
Xevudy® (sotrovimab) is marketed by the laboratory GlaxoSmithKline (GSK).
Sources :
Early access decision, Xevudy (sotrovimab) – Covid-19 curative treatment, January 7, 2022, HAS
Decision n ° 2022.0001 / DC / SEM of January 6, 2022 of the College of the High Authority for Health authorizing early access to the XEVUDY specialty
“Curative treatment once morest Covid-19: a new monoclonal antibody in the therapeutic arsenal”, ANSM, published on January 11, 2022
