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 against the Omicron variant of Covid-19? Its side effects?
In one review published on January 7, 2022, the French National Authority for Health (HAS) has granted post-MA early access authorization (marketing authorisation) 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 Alzheimer’s disease coronavirus 2019 (Covid-19) that do not require supplemental oxygen and are at risk of progressing to severe Covid-19“. What are the exact indications for this treatment? Is it effective against 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 monoclonal antibody treatment authorized in curative and whose neutralizing activity should be retained against the Omicron variant“, according to the National Agency for the Safety of Medicines and Health Products (ANSM).
What are the indications in France?
The French National Authority for Health (HAS) has granted post-MA early access authorization (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 coronavirus disease 2019 (Covid-19) that do not require supplemental oxygen and are at risk of progressing to severe Covid-19“namely the following populations as defined by the ANRS-Emerging Infectious Diseases:
- Patients 80 years and older;
- Patients with an immunity deficiency linked to a pathology or treatment:
- Current chemotherapy,
- Solid Organ Transplantation,
- Allogeneic Hematopoietic Stem Cell Transplantation,
- Systemic or vascular lupus with immunosuppressive therapy,
- 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 hypertension,
- 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 its 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 fromEuropean Medicines Agency (EMA) on December 17, 2021. HAS recalls that Xevudy does not exempt patients from compliance with barrier and physical distancing measures and that this medicine is not intended to be used as a substitute for vaccination against Covid-19.
How effective against 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 action in eliminating the cells already infested. “This monoclonal antibody presents a mechanism of action which makes it possible to hope for the maintenance of its effectiveness on the variants, including the variant omicron” emphasizes the HAS. According to the 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) dabout 80% (COMET-ICE study) after 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” indicates the European Medicines Agency (EMA). The side effects are: rash or redness, itching, difficulty in breathing, feeling dizzy. Finally, the infusion for the administration of Xevudy present the risk of adverse effects : flushing, chills, fever, difficulty breathing, rapid heartbeat, low 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 after administration“, indicates the HAS. It is recommended toadminister within 5 days of onset of Covid-19 symptoms“says the HAS.
Which laboratory markets Xevudy?
Xevudy® (sotrovimab) is marketed by the laboratory GlaxoSmithKline (GSK).
Early access decision, Xevudy (sotrovimab) – Covid-19 curative treatment, 7 January 2022, HAS
Decision n° 2022.0001/DC/SEM of January 6, 2022 of the college of the High Authority for Health authorizing early access for the proprietary medicinal product XEVUDY
“Curative treatment against Covid-19: a new monoclonal antibody in the therapeutic arsenal”, ANSM, published on January 11, 2022