Actemra

First Monoclonal Antibody to Treat COVID-19 Approved

Donald Hackett — Thu, 22 Dec 2022 18:50:12 +0000

Reviewer:

The first monoclonal antibody (mAbs) to treat COVID-19 has joined a short list of U.S. Food and Drug Administration (FDA) approved antivirals.

Roche announced yesterday that the FDA had approved Actemra® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adult patients receiving systemic corticosteroids and requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Since the beginning of the pandemic in 2020, more than one million people hospitalized with COVID-19 have been treated with Actemra worldwide, said Roche's press release on December 21, 2022.

"With new variants emerging, FDA-approved treatments, including Actemra, remain essential to the continued fight against COVID-19," commented Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Roche's Global Product Development.

"Actemra is the first FDA-approved mAbs 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."

In the U.S., this is the seventh FDA-approved indication for Actemra since 2010.

The new approval follows the FDA's Emergency Use Authorization (EUA) for Actemra in hospitalized adults and children (2 yrs.+) with COVID-19, granted in June 2021.

The December 2022 approval is based on the results from the RECOVERY trial and the EMPACTA trial, the first global, Phase III study in COVID-19 to focus on patients from underrepresented racial and ethnic groups.

Actemra is recommended for use as a single 60-minute IV infusion.

No new warnings and precautions related to Actemra in COVID-19 studies have been identified.

Furthermore, the use of Actemra to treat hospitalized people ages 2 to less than 18 years old is not FDA-Approved.

Around the world, Actemra is approved for use in more than 30 countries. However, the EUA for this age group remains in place after yesterday's FDA approval for hospitalized adult patients.

Moreover, the World Health Organization has prequalified Actemra for use in patients with severe COVID-19, facilitating its availability in low- and middle-income countries.

Currently, the U.S. Centers for Disease Control and Prevention lists oral Paxlovid®, Veklury, and Lagevrio as approved antivirals.

And in Europe, several antivirals have been authorized.

Actemra® (RoActemra®) was the first humanized interleukin-6 receptor antagonist approved for treating adult patients with moderately to severely active rheumatoid arthritis who have used one or more disease-modifying antirheumatic drugs, such as methotrexate, that did not provide enough relief.

Roche continues to evaluate its therapeutic portfolio and is researching future options to help benefit patients with COVID-19.

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Roche Actmera monoclonal antibody approved to treat COVID-19

References:

U.S. FDA approves Roche’s Actemra

CDC: COVID-19 Treatments and Medications

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RA Drug Reduces Mortality Risk in Severely Ill COVID-19 Patients

Don Hackett — Mon, 08 Mar 2021 21:26:18 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

The results of a recent clinical trial conducted in hospitals across India found an anti-inflammatory drug used to treat rheumatoid arthritis improves health outcomes in severely ill COVID-19 patients.

Published in The Lancet Respiratory Medicine on March 4, 2021, researchers from the University of Bristol and Medanta Institute of Education and Research in India found evidence supporting the use of Tocilizumab (Actemra) in critically ill patients.

Analysis of the study’s data revealed a subset of patients with severe disease in whom tocilizumab might have a reduced risk for progression to death if treated with tocilizumab in addition to standard care.

However, clinical parameters or biomarkers to reliably identify these patients and the optimal timing of treatment during COVID-19 progression remain unknown.

The study authors concluded that while this study does not support the routine use of tocilizumab in adults with COVID-19, it adds to the growing evidence suggesting it may help some severely ill patients.

The trial's co-author, Professor A. V. Ramanan from the University of Bristol's School of Clinical Sciences, and Consultant Paediatric Rheumatologist at Bristol Royal Hospital for Children, said in a related press release, "Our study suggests tocilizumab might still be effective in patients with severe COVID-19 and so should be investigated further in future studies.”

“It adds to existing evidence from the RECOVERY and REMAP-CAP studies which demonstrate that tocilizumab does have a significant impact on reducing mortality in those with COVID-19 requiring oxygen or being ventilated.”

"After dexamethasone (steroids), this is still the most significant advance in the treatment of COVID that has an impact in reducing deaths."

Lead author Dr. Arvinder Soin, Chairman of the Medanta Liver Transplantation Institute at Gurugram, India, said: "While there were no differences in mortality and the need for ventilation among the two groups of patients when moderate and severe categories of patients were considered together, a subgroup analysis of the severe patients in the two groups showed lower mortality at 28 days (8/50; 16 percent) among those who received tocilizumab compared to those who did not (14/41; 34 percent). The reported adverse events did not differ between the tocilizumab and standard care arms.

"Given the conflicting results of the previous studies, millions were wasted last year on the indiscriminate use of tocilizumab, as the precise stage of the disease in which to use the drug was not clear.”

“This study plugs an important gap in knowledge on COVID treatment and clarifies that tocilizumab should be administered to patients in the severe category. Incidentally, last month, two major studies from the UK - the RECOVERY Trial and the REMAP-CAP study - have revealed similar findings, that tocilizumab reduces mortality among patients with severe COVID-19."

Conducted in 12 public and private hospitals across India, the COVID India Tocilizumab (COVINTOC) phase 3 randomized controlled trial aimed to investigate whether tocilizumab could prevent disease progression and mortality in hospitalized patients with moderate to severe COVID-19.

The study team recruited 180 patients (age 18-years and over) who had been hospitalized with moderate to severe COVID-19. Of these, 89 patients were randomized to receive standard care, and 91 patients were randomized to receive standard care plus tocilizumab.

Patients were followed up over 28 days to record any clinical improvement markers and assess disease progression from moderate to severe or from severe to death. The team also recorded whether patients experienced adverse events, serious adverse events, and post-treatment infections, and requirements for renal replacement drugs.

The trial was conducted against incredible odds across multiple sites under challenging conditions in a country with the second-highest COVID-19 caseload in the world.

The study was funded by the Medanta Institute of Education and Research, Roche India, Cipla India, and Action COVID-19 India.

Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for treating adult patients with moderately to severely active rheumatoid arthritis who have used one or more disease-modifying antirheumatic drugs that did not provide enough relief. The U.S. FDA approved Actemra in 2010.

PrecisionVaccinations publishes research-based news.

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Tocilizumab (Actemra) was the first humanized interleukin-6 receptor antagonist approved for the treatment of active rheumatoid arthritis

References:

Tocilizumab plus standard care versus standard care in patients in India with moderate to severe COVID-19-associated cytokine re

Actemra (Tocilizumab)

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COVID-19 Patients in the UK to Receive New Treatments that Reduce Hospitalization

Don Hackett — Thu, 07 Jan 2021 20:26:36 +0000

Reviewer:

Robert Carlson, MD

Patients across the United Kingdom (UK) admitted to intensive care units due to COVID-19 are set to receive new treatments that can reduce hospital time by up to 10 days.

The UK’s Department of Health and Social Care announced the results from the government-funded REMAP-CAP clinical trial showed tocilizumab and sarilumab reduced the relative risk of death from COVID-19 by 24 percent when administered to patients within 24 hours of entering intensive care.

Patients receiving these drugs, typically used to treat rheumatoid arthritis, left intensive care between 7 to 10 days earlier on average. Therefore, this treatment rollout could significantly reduce pressure on hospitals over the coming weeks and months.

Most of the data from this study came when the drugs were administered in addition to a corticosteroid, such as dexamethasone, also discovered through UK-backed research through the RECOVERY clinical trial, which is already provided as the standard of care to the UK’s National Health Service (NHS).

The UK government issued the updated treatment guidance on January 8, 2021, said the press release.

Supplies of tocilizumab are already available in hospitals across the UK, and clinicians will be able to treat all those admitted to intensive care units, potentially saving hundreds of lives. The department is working closely with Roche, who manufactures tocilizumab, to ensure treatments continue to be available to UK patients.

UK Health and Social Care Secretary Matt Hancock said: “Today’s results are yet another landmark development in finding a way out of this pandemic and, when added to the armory of vaccines and treatments already being rolled out, will play a significant role in defeating this virus.”

We have worked quickly to ensure this treatment is available to NHS patients without delay, meaning hundreds of lives will be saved.”

In June last year, the UK government approved dexamethasone as the world’s first treatment proven to reduce mortality for COVID-19. The REMAP-CAP trial found that the death rate for those in intensive care units on corticosteroids, such as dexamethasone, and respiratory support alone was 35 percent, which was reduced to 28 percent when tocilizumab was also administered.

Professor Stephen Powis, NHS national medical director, added: “The fact there is now another drug that can help to reduce mortality for patients with COVID-19 is hugely welcome news and another positive development in the continued fight against the virus.”

“This signals how the NHS is working all the time to find new treatments and therapies, but the best advice for individuals is to remember the hands, face, space guidance.”

The REMAP-CAP analysis has not yet been peer-reviewed.

Tocilizumab is administered intravenously in a one or two-dose regime. It has been demonstrated to be useful for patients requiring organ support when administered soon after admission to ICU.

Other trials, such as the RECOVERY trial, are assessing efficacy in broader patient groups outside of intensive care settings, but these are still ongoing. REMAP-CAP has not tested the effectiveness of tocilizumab in primary care settings. Tocilizumab will be used to further reduce mortality from COVID-19 and in addition to dexamethasone, which is already standard of care for hospitalized patients receiving supplemental oxygen.

Tocilizumab and sarilumab have already been added to the government’s export restriction list, which bans companies from buying medicines meant for UK patients and selling them for a higher price in another country. This will protect supply for UK patients by enforcing regulatory action on those who disregard the restrictions.

The National Health Service is the umbrella term for the publicly-funded healthcare systems of the UK.

CoronavirusToday publishes research-based news.

Sub Title:

REMAP-CAP study showed tocilizumab and sarilumab significantly reduced the relative risk of death from COVID-19

References:

NHS patients to receive life-saving COVID-19 treatments that could cut hospital time by 10 days

REMAP-CAP

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