FDA Authorizes the Drug Actemra for COVID-19 Treatment

On 24 June 2021, FDA (the US Food and Drug Administration) authorized treatment for hospitalized patients receiving corticosteroids and requiring non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) with supplemental oxygen in adult and pediatric patients (aged 2 years and older) with COVID-19 using tocilizumab, the active ingredient in Actemra, through an emergency use authorization. Although this is not an “approval,” it could become a final approval if positive scientific evidence continues to emerge.

In clinical trials involving hospitalized patients with COVID-19, Actemra was shown to reduce the risk of death and the length of hospital stay over a 28-day follow-up that included corticosteroid therapy in addition to the routine care patients received for COVID-19. The risk of patients requiring intubation or dying during the 28-day follow-up was also reduced.

New treatments are becoming available at every stage of the COVID-19 pandemic. Although vaccines have been successful in reducing the number of COVID-19 patients requiring hospitalization, providing additional treatments for those who are hospitalized is an important step in fighting this pandemic.

Which vaccines and treatments have received FDA emergency use authorization?

The vaccines that have received FDA emergency use authorization to prevent COVID-19 so far are:

• BioNTech COVID-19 vaccine (11.12.2020)
• Moderna COVID-19 vaccine (18.12.2020)
• Janssen COVID-19 vaccine (27.02.2021)

The drugs that have received FDA emergency use authorization for COVID-19 treatment so far are:

• Remdesivir (01.05.2020)
• Baricitinib (Olumiant) combined with remdesivir (Veklury) (19.11.2020)
• REGEN-COV (Casirivimab and Imdevimab) (21.11.2020)
• Bamlanivimab and Etesevimab (09.02.2021)
• Sotrovimab (26.05.2021)
• Actemra (Tocilizumab) (24.06.2021)

How does Actemra work?

Actemra is a monoclonal antibody that blocks the interleukin-6 receptor to reduce inflammation.

In COVID-19 infection, the immune system can become hyperactive, which can worsen the disease. Actemra does not directly target SARS-COV-2. Actemra is a prescription drug given by intravenous infusion that is FDA-approved for several inflammatory diseases, including rheumatoid arthritis. Under this emergency use authorization, the FDA is authorizing the emergency use of Actemra to treat certain hospitalized patients with COVID-19. Actemra is not approved as a COVID-19 treatment.

The FDA’s issuance of an emergency use authorization differs from FDA approval. When deciding whether to issue an emergency use authorization, the FDA evaluates the totality of available scientific evidence and carefully balances the known or potential benefits against the known or potential risks of the product for use in an emergency. Based on its review of the totality of available scientific evidence, the agency determined that it was reasonable to believe Actemra might be effective in treating COVID-19 in a particular group of patients. This means that, when used to treat COVID-19 in patients meeting these conditions, Actemra’s known and potential benefits outweigh its known and potential risks.

In Turkey Actemra was first licensed on 11.02.2020 for the treatment of highly active rheumatoid arthritis meeting certain conditions, active systemic juvenile idiopathic arthritis and Giant Cell Arteritis.

If Actemra is to be used in a COVID-19 patient in Turkey, the physician following the patient applies to the Ministry of Health on a patient-by-patient basis.

Clinical studies of Actemra in COVID-19 treatment

The data supporting this emergency use authorization for Actemra come from 4 clinical trials. These include one randomized, controlled, open-label platform trial [Randomised Evaluation of COVID-19 Therapy (RECOVERY)] and three randomized, double-blind, placebo-controlled studies (EMPACTA, COVACTA and REMDACTA). Although all four clinical trials contributed to the FDA’s understanding of Actemra for COVID-19 treatment, the most important scientific evidence regarding its potential benefit for the authorized use came from the RECOVERY and EMPACTA trials.

In the RECOVERY study, 4,116 hospitalized patients with severe COVID-19 pneumonia were randomized to receive Actemra in addition to usual care (2,022 patients) or usual care alone (2,094 patients). The study’s primary endpoint assessed death over a 28-day follow-up, and the primary analysis results were statistically significant. The follow-up point for the mortality estimates was day 28. These probabilities were estimated at 30.7% for patients receiving Actemra and 34.9% for those receiving usual care alone. The average time to hospital discharge was 19 days for patients receiving Actemra and more than 28 days for those receiving usual care alone.

In the EMPACTA study, 389 hospitalized patients with COVID-19 pneumonia were randomized to Actemra (249 patients) or placebo (128 patients). The primary endpoint assessed the need for mechanical ventilation or death over a 28-day follow-up. Patients receiving Actemra had an observed reduction in progression to mechanical ventilation or death compared with those receiving placebo, and the primary analysis results were statistically significant. The proportion of patients requiring mechanical ventilation or dying was assessed through day 28. It was estimated at 12% for patients receiving Actemra and 19.3% for patients receiving placebo.

In the COVACTA study, 452 hospitalized patients with severe COVID-19 pneumonia were randomized to receive Actemra (294 patients) or placebo (144 patients). The primary endpoint was clinical status over a 28-day follow-up, assessed on a 7-category ordinal scale. The comparison of clinical status between treatment groups on the 7-category ordinal scale was made on day 28. No statistically significant difference was observed, but the COVACTA study contributed to assessing the safety of Actemra when used for COVID-19 treatment.

In the REMDACTA study, 649 hospitalized patients with severe COVID-19 pneumonia were randomized to receive Actemra with remdesivir (430 patients) or placebo with remdesivir (210 patients). The primary endpoint was time to hospital discharge or being “ready for discharge” during a 28-day follow-up. In addition, although no statistically significant difference was observed between treatment groups in time to hospital discharge or being “ready for discharge” over the 28-day follow-up, the REMDACTA trial contributed to assessing Actemra’s safety in COVID-19 treatment.

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RELATED TOPICS

• Current Covid-19 statistics for the world and Turkey
• Latest coronavirus news and scientific developments

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