On June 4, 2021, the dose of casirivimab and imdevimab monoclonal antibody cocktail authorized by the Food and Drug Administration (FDA) was lowered from 2400 mg to 1200 mg—600 mg of each agent administered as a single infusion or injection. This antibody combination is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric […]
On May 26, 2021, a new COVID-19 monoclonal antibody therapy—sotrovimab (previously VIR-7831)— was added to the list of infusion therapies authorized by the Food and Drug Administration for non-hospitalized people 12 years of age and older and weighing at least 40 kg, who have mild-to-moderate COVID-19 and risk factors for progressing to severe disease.1 Rather
New COVID-19 Monoclonal Antibody Granted Emergency Use Authorization Read More »
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Copyright © 2019 Med Learning Group. Website by Divigner. All Rights Reserved.
Esta actividad es co-proporcionada por Ultimate Medical Academy / Complete Conference Management (CCM).
Esta actividad cuenta con el apoyo de subvenciones educativas de AbbVie, Astellas, Genentech, Lilly, Merck & Co., Inc., Pfizer y Regeneron Pharmaceuticals, Inc.
Copyright © 2019 Med Learning Group. Sitio web de Divigner. Todos los derechos reservados.
EUA of Bamlanivimab Plus Etesevimab Expanded to Include Younger Pediatric Patients
The emergency use authorization (EUA) for bamlanivimab plus etesevimab now includes an indication for treatment and post-exposure prophylaxis for children and newborn babies who are at high risk for severe disease. The expansion of the EUA is supported by a trial of 125 pediatric patients with at least one risk factor for severe illness; the study had safety and efficacy data similar to findings for adolescents and adults.
For more information visit www.fda.gov/news-events/press-announcements/fda-expands-authorization-two-monoclonal-antibodies-treatment-and-post-exposure-prevention-covid-19
Oral Antiviral Therapies With Emergency Use Authorization (EUA) for COVID-19
Two new oral antiviral therapies received emergency use authorization (EUA) for COVID-19: Paxlovid™ (nirmatrelvir tablets and ritonavir tablets, co-packaged) and molnupiravir. Both therapies are authorized for the treatment of mild-to-moderate COVID-19 in certain people who are at high risk of progressing to severe illness.
In the EPIC-HR clinical trial, nirmatrelvir/ritonavir significantly reduced the risk of hospitalization or death from any cause by 88% compared with placebo. This treatment is indicated for adults and pediatric patients, 12 years of age and older who weigh at least 40 kilograms. Side effects include an impaired sense of taste, diarrhea, high blood pressure, and muscle aches. The safety and effectiveness of this combination therapy continue to be evaluated.
The main outcome measure of the MOVe-OUT trial of molnupiravir was the percentage of people who were hospitalized or died due to any cause during 29 days of follow-up. Compared with 9.7% of people who received placebo, 6.8% of those in the molnupiravir group were hospitalized or died. One person who received molnupiravir died versus nine people in the placebo group. Molnupiravir is not recommended for pregnant women or for those people younger than 18 years of age because of its effect on bone and cartilage growth.
For more information regarding the EUA for these oral antivirals, visit the following FDA URLs:
FDA Authorized Emergency Use Authorization (EUA) for Long-Acting Monoclonal Antibodies as Pre-Exposure Prophylaxis of COVID-19
Evusheld™ (tixagevimab co-packaged with cilgavimab and administered together) has been granted EUA for the prevention of COVID-19 in certain people with compromised immune systems or with a history of severe adverse reactions to a COVID-19 vaccine or any of its components. This combination is not meant to be a substitute for vaccination for those who have no contraindications to a COVID-19 vaccine.
The PROVENT clinical trial demonstrated a 77% reduction in the risk of developing COVID-19 compared with placebo, and protection appears to have been maintained through six months. Safety and efficacy of the tixagevimab/cilgavimab combination continues to be investigated.
For more information, visit www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure
Un candidato a antiviral oral COVID-19 en investigación redujo el riesgo de hospitalización o muerte en un 89% en un análisis intermedio
Un candidato antiviral oral en investigación que consta de PF-07321332 más ritonavir (Paxlovid ™) redujo significativamente la hospitalización y la muerte en pacientes adultos no hospitalizados con COVID-19 con alto riesgo de progresar a una enfermedad grave. Un análisis intermedio del ensayo de fase 2/3 EPIC-HR mostró una reducción del 89% en el riesgo de hospitalización asociada a COVID-19 o muerte por cualquier causa el día 28 en el grupo antiviral en comparación con el grupo placebo en pacientes tratados dentro de tres días de inicio de los síntomas (0,8% frente a 7,0%, respectivamente; p <0,0001). Se observaron resultados similares en pacientes tratados dentro de los cinco días posteriores al inicio de los síntomas (1,0% frente a 6,7%; P <0,0001). No se informaron muertes en pacientes que recibieron el tratamiento antiviral en comparación con 10 muertes (1,6%) en pacientes que recibieron placebo. Los eventos adversos emergentes del tratamiento fueron comparables entre los grupos de tratamiento antiviral (19%) y placebo (21%) y fueron en su mayoría de intensidad leve. Se observaron menos eventos adversos graves (1,7% frente a 6,6%) y la interrupción del fármaco del estudio debido a eventos adversos (2,1% frente a 4,1%) en los pacientes que recibieron el tratamiento antivírico en comparación con placebo, respectivamente.
Referencia:
Mahase E. Covid-19: Paxlovid de Pfizer es 89% efectivo en pacientes con riesgo de enfermedad grave, informa la compañía. BMJ. 2021; 375: n2713. Disponible en https://www.bmj.com/content/375/bmj.n2713
