Monday, December 5, 2022
HomeHealthcareRoche antibody is authorized by the FDA to treat hospitalized Covid-19 patients

Roche antibody is authorized by the FDA to treat hospitalized Covid-19 patients


When Covid-19 infection develops into a serious disease, the immune system may become one of the patients’ biggest threats. In some people, the immune response is overactive, leading to excessive inflammation.A Roche drug approved to treat inflammation associated with rheumatoid arthritis is now available Emergency authorization Solve the excessive inflammation in Covid-19 and provide new treatment options for hospitalized patients.

Roche’s drug tocilimab (Actemra) is an intravenous infusion of antibodies. Emergency use authorization is for adults who are receiving corticosteroid therapy and need additional measures to help breathe, and children 2 years and older.

The FDA has authorized other antibody drugs to treat Covid-19, such as those from Eli Lilly (Although the transportation of the drug has been suspended, see below), Regeneron Pharmaceutical, And partners For biotechnology and GlaxoSmithKline. These drugs directly target the SARS-CoV-2 virus itself.

Actemra does not target viruses. The immune response to Covid-19 may include the production of pro-inflammatory proteins such as interleukin 6 (IL-6). Actemra is designed to block IL-6 receptors. This mechanism makes it more like a different Eli Lilly antibody, baricitinib (Olumiant), a Janus kinase (JAK) inhibitor that blocks JAK enzymes associated with inflammation.At the end of last year, the FDA granted Lighting emergency authorization Used to treat Covid-19.

Actemra’s authorization is the latest stop in a more than one-year journey of Covid-19 drug evaluation. The antibody was tested in four clinical trials. Phase 3 trial in patients with Covid-19 pneumonia Failed last July. Last September, a Different Phase 3 studies show statistically significant improvements Reduce the number of patients whose disease progresses to requiring ventilators for more than 28 days. According to the FDA, the study of 389 patients and the clinical trials of another 4,116 patients provide the most important evidence for Actemra’s potential benefits.

In a study of 4,116 patients with Covid pneumonia, it was estimated that the probability of death on the 28th day for patients treated with Actemra was 30.7%. Among those who were given the standard of care, the estimated value was 34.9%. The difference is enough to be statistically significant. The median time to discharge in the Actemra group was 19 days, compared to more than 28 days in patients receiving standard care.

Actemra is not without risks. In rheumatoid arthritis and other inflammatory diseases, the drug’s label carries a black box warning, warning that serious opportunistic infections leading to hospitalization and death have been observed in patients receiving the drug. FDA’s Fact Sheet Healthcare providers have also flagged these risks and warned that the drug should not be prescribed to people who also have active infections diagnosed with Covid-19. Gastrointestinal perforation and liver toxicity are other complications observed in Actemra’s Covid-19 clinical trial.

In other recent Covid-19 news:

• Federal officials suspended the shipment of Eli Lilly’s Covid-19 antibody cocktail on Friday.Wall Street Journal Report The action was taken after tests showed that bamlanivimab and etesevimab (two antibodies containing the drug) were ineffective against the Gamma variant first discovered in Brazil and the Beta variant first discovered in South Africa. In April, the FDA revoked the separate emergency authorization of bamlanivimab due to the invalidity of the variant.

• FDA approved Gilead Sciences Covid-19 antiviral drug remdesivir (Veklury) based on clinical trial data of approximately 2,000 patients. Real data of approximately 98,654 hospitalized patients were reported Last week, additional support was provided for the use of the drug.

• Vir Biotechnology and GlaxoSmithKline report positive Phase 3 data Used for the intramuscular injection of its Covid-19 antibody drug sotrovimab.One The IV version of the drug was authorized for emergency use last month.

• Theravance Biopharma’s experimental inhaled JAK inhibitor nezulcitinib, lose A phase 2 study tested it as a treatment for Covid-19 patients hospitalized with acute lung injury.

• Roche’s cobas Liat diagnostic system is approved Emergency use authorization Used for PCR testing of symptomatic and asymptomatic people at the point of care. The company says its system can produce results in about 20 minutes.

Photo: Giuseppe Aresu/Bloomberg via Getty Images



Source link

RELATED ARTICLES

Most Popular

Recent Comments