{"id":52259,"date":"2022-12-21T22:02:05","date_gmt":"2022-12-21T21:02:05","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fda-approves-genentechs-actemra-for-the-treatment-of-covid-19-in-hospitalized-adults\/"},"modified":"2022-12-21T22:02:05","modified_gmt":"2022-12-21T21:02:05","slug":"fda-approves-genentechs-actemra-for-the-treatment-of-covid-19-in-hospitalized-adults","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fda-approves-genentechs-actemra-for-the-treatment-of-covid-19-in-hospitalized-adults\/","title":{"rendered":"FDA Approves Genentech\u2019s Actemra for the Treatment of COVID-19 in Hospitalized Adults"},"content":{"rendered":"
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\n\u2013 Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 \u2013<\/i>\n<\/p>\n

\n\u2013 Since the beginning of the pandemic, more than one million people hospitalized with COVID-19 have been treated with Actemra worldwide \u2013<\/i>\n<\/p>\n

\n\u2013 Actemra is approved for this use in more than 30 countries for the treatment of COVID-19 \u2013<\/i>\n<\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Actemra\u00ae<\/sup> (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion.\n<\/p>\n

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\n\u201cWith new variants emerging, FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19,\u201d said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. \u201cActemra is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalized patients and their healthcare providers who continue to be on the frontlines treating COVID-19.\u201d\n<\/p>\n

\nFour randomized, controlled studies evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. Altogether, the results of these four studies (the University of Oxford-led RECOVERY trial, along with the Genentech-sponsored global trials, EMPACTA, COVACTA and REMDACTA) showed that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support. The FDA approval is based on the results from the RECOVERY trial, as well as the EMPACTA trial, the first global, Phase III study in COVID-19 to focus on patients from underrepresented racial and ethnic groups. No new warnings and precautions related to Actemra in COVID-19 studies have been identified. The most common adverse reactions seen (incidence \u2265 3%) are constipation, urinary tract infection, hypertension, anxiety, diarrhea, insomnia and nausea.\n<\/p>\n

\nThe FDA approval follows the FDA\u2019s Emergency Use Authorization (EUA) for Actemra in hospitalized adults and children (ages 2 and older) with COVID-19, which was granted in June 2021. The use of Actemra to treat hospitalized people ages 2 to less than 18 years old is not FDA approved, however the EUA for this age group currently remains in place after the FDA approval for hospitalized adult patients.\n<\/p>\n

\nGenentech and Roche are committed to providing consistent, uninterrupted patient access to Actemra for all approved indications. The worldwide manufacturing capacity of Actemra has significantly increased in 2022, resulting in all configurations of Actemra IV and Actemra subcutaneous (SC) being available at levels sufficient to meet patient demand. The most up-to-date information about the supply of Actemra in the U.S. can be found here<\/a>. Actemra SC is not authorized for the treatment of COVID-19 patients.\n<\/p>\n

\nMore than one million people hospitalized with COVID-19 have been treated with Actemra worldwide since the beginning of the pandemic. Around the world, Actemra is approved for use in more than 30 countries for patients hospitalized with severe COVID-19. In the U.S., this is the seventh FDA approved indication for Actemra since the medicine was launched in 2010.\n<\/p>\n

\nGenentech stands together with society, governments, healthcare providers and all those working towards the common goal of overcoming the COVID-19 pandemic.\n<\/p>\n

\nAbout Actemra in COVID-19<\/b>\n<\/p>\n

\nActemra is approved for use in multiple territories including the United States, European Union, Japan, the United Kingdom, New Zealand, Russia and Brazil, provisionally approved in Australia, and authorized for emergency use in Ghana, Mexico and Korea for defined patients hospitalized with severe or critical COVID-19. It has also been recommended and prequalified by the World Health Organization.\n<\/p>\n

\nAbout Actemra<\/b>\n<\/p>\n

\nActemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. Actemra subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis (GCA), for the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA), and for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). In addition, Actemra is also approved in the IV formulation for patients two years of age and older with active PJIA, SJIA, GCA or CAR T cell-induced cytokine release syndrome (CRS). Actemra is not approved for subcutaneous use in people with CRS. Actemra IV is approved for the treatment of COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). It is not known if Actemra is safe and effective in children with PJIA, SJIA or CRS under two years of age or in children with conditions other than PJIA, SJIA or CRS.\n<\/p>\n

\nActemra is intended for use under the guidance of a healthcare practitioner.\n<\/p>\n

\nIMPORTANT SAFETY INFORMATION ABOUT ACTEMRA FOR COVID-19<\/b>\n<\/p>\n

\nACTEMRA can cause serious side effects<\/b>\n<\/p>\n

\nSerious Infections<\/b>\n<\/p>\n

\nACTEMRA changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. Some people have died from these infections. Your healthcare provider should assess you for TB before starting and during treatment with ACTEMRA (except if you have COVID-19).<\/b>\n<\/p>\n

\nBefore starting ACTEMRA, tell your healthcare provider if you have:\n<\/p>\n