FDA Authorizes Roche’s COVID-19 Monoclonal Antibody

On Wednesday, December 21, Roche Holding AG (ROG.S) announced that the U.S. Food and Drug Administration (FDA) authorized the use of its monoclonal antibody Actemra to treat COVID-19 infections in hospitalized adult patients.

Monoclonal antibody drugs refer to treatments that enroll your body's immune system against certain diseases.

Actemra, which is intended to diminish inflammation, was authorized in 2010 to treat rheumatoid arthritis. Last June, the FDA granted the emergency use authorization of Actemra to treat severe cases of COVID-19, making it the first FDA-authorized monoclonal antibody to target the disease.

“Actemra 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,” said Roche’s chief medical officer Levi Garraway in an official statement.

In November 2022, the authorization for Eli Lilly and Co's (LLY.N) COVID-19 monoclonal antibody, bebtelovimab, was withdrawn as it was found to not target the dominant BQ.1 and BQ.1.1 subvariants of the Omicron variant. The government shared that the BQ.1 and BQ.1.1 subvariants attributed to approximately 69 percent of COVID-19 cases in the United States as of the 2nd week of December. Now, COVID-19 patients who are on specific steroids and need supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) may be given the Roche drug Actemra.​​

What other COVID-19 treatments are there?

COVID-19 can look different for each individual. It can come to some people like the common flu, or as a fatal virus to certain individuals. While some people can stay home and naturally wait for the virus to heal on its own, some individuals require medications and treatments to get better. As of today, the FDA authorized antiviral medications to treat mild and moderate COVID-19 in patients who are more vulnerable to the virus.

Antiviral treatments aim for the virus to stop spreading in the body, preventing potential serious illness or even death. There is Paxlovid for those who are 12 and older and can be prescribed to take orally. There is also Veklury and Lagevrio you can take to diminish the symptoms. It is crucial to consult with medical professionals to see which treatment would work best. For most individuals, COVID-19 can be fought off by over-the-counter medications such as Tylenol, Advil, or Motrin. There are also COVID-19 vaccines available in the United States to prevent severe illnesses or hospitalization, or even death.

The FDA also authorized the emergency use of Tixagevimab and cilgavimab, a preventive medication that can protect one from getting COVID-19. EVUSHELDTM has two separate antibodies and is injected at a healthcare facility before getting COVID-19. The preventative medication is intended for those who are moderately or severely immunocompromised, or seriously allergic to COVID-19 vaccines. EVUSHELDTM may be injected every 6 months to protect yourself from the virus.

What is long COVID-19?

COVID-19 can usually be treated on its own with time and proper care. Despite testing negative and recovering from the infection, some struggle with long COVID-19, or post-COVID symptoms. Post-COVID symptoms can last anywhere from weeks to months, to even years after the infection. The virus affects everyone differently, and long COVID-19 signs can look different for everyone.

Some common symptoms people experience after recovery are fatigue, post-exertional malaise, to respiratory and heart symptoms such as chest pain and cough. It can also lead to mental and neurological symptoms such as brain fog, sleep complications, and depression.

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