Astepro Allergy Approved Under Partial Rx-to-OTC Switch
June 17, 2021Toviaz Receives New Indication to TreatNeurogenic Detrusor Overactivity in Children
June 24, 2021Actemra Receives Emergency Use Authorization to Treat COVID-19
June 24, 2021 – The U.S. FDA has granted emergency use authorization (EUA) to Actemra® (tocilizumab – Genentech) to treat COVID-19 in hospitalized patients who are at least two years old; receiving systemic corticosteroids; and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is not authorized for use in outpatients diagnosed with COVID-19.
Although Actemra is an FDA-approved drug, the EUA does not represent FDA approval for its use in treating COVID-19. Instead, the EUA allows the FDA to make Actemra available to treat COVID-19 during a public health emergency in the absence of sufficient FDA-approved COVID-19 treatments. EUAs are granted based on the totality of current scientific evidence and require that the known and potential benefits of the treatment at that time outweigh the known and potential risks.
In clinical trials of patients hospitalized with COVID-19, Actemra added to routine COVID-19 care, which included corticosteroid therapy, reduced the risk of death through 28 days of follow up and decreased length of hospitalization. It also reduced the risk of being placed on a ventilator.
Actemra is a monoclonal antibody that blocks interleukin-6 receptors on cell surfaces. This stops inflammation, which in COVID-19 can occur due to an overactive immune response. To treat COVID-19, Actemra is administered as a single, 60-minute intravenous infusion at a recommended dose of 12mg/kg of body weight [patients weighing less than 30kg (66 pounds)] or 8mg/kg (patients weighing 30kg or more). If clinical signs or symptoms worsen or do not improve after the first dose, one additional infusion can be administered at least eight hours after the initial infusion. The dose in patients diagnosed with COVID-19 should not exceed 800mg per infusion.
FDA approved in 2010, Actemra is indicated to treat inflammatory conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, and cytokine release syndrome. Its prescribing information includes a black box warning that serious, potentially fatal opportunistic infections, including tuberculosis, have occurred in patients receiving the medication.