Roche antibody gets FDA authorization for treating hospitalized Covid-19 patients

 

When Covid-19 infection progresses to severe disease, the immune system can become one of a patient’s greatest threats. In some people, the immune response is hyperactive, sparking excessive inflammation. A Roche drug approved to treat the inflammation associated with rheumatoid arthritis now has emergency authorization to address hyperinflammation in Covid-19, offering a new treatment option for hospitalized patients.

The Roche drug, tocilimab (Actemra), is an antibody given as an intravenous infusion. The emergency use authorization covers adults, as well as children 2 and older, who are receiving corticosteroid treatment and require additional measures to help their breathing.

The FDA has authorized other antibody drugs for treating Covid-19, such as medicines from Eli Lilly (though shipments of that drug have been paused, see below), Regeneron Pharmaceuticals, and partners Vir Biotechnology and GlaxoSmithKline. Those drugs directly target the SARS-CoV-2 virus itself.

Actemra does not target the virus. The immune response to Covid-19 can include production of proinflammatory proteins, such as interleukin-6 (IL-6). Actemra is designed to block the IL-6 receptor. That mechanism makes it more like a different Eli Lilly antibody, baricitinib (Olumiant), a Janus kinase (JAK) inhibitor that blocks JAK enzymes associated with inflammation. Late last year, the FDA granted Olumiant emergency authorization for treating Covid-19.

Authorization for Actemra is the latest stop in a more than year-long journey evaluating the drug in Covid-19. The antibody was tested in four clinical trials. A Phase 3 test in patients with Covid-19 pneumonia failed last July. Last September, a different Phase 3 study showed statistically significant improvement in reducing the number of patients whose condition progressed to requiring a ventilator over 28 days. That FDA said that 389-patient study, as well as another 4,116-patient clinical trial, provided the most important evidence on Actemra’s potential benefit.

In the 4,116-patient study, which enrolled those with Covid pneumonia, the probability of death by day 28 was estimated to be 30.7% for those treated with Actemra. In those given the standard of care, the estimate was 34.9%. The difference was enough to be statistically significant. The median time to hospital discharge was 19 days in the Actemra group compared to more than 28 days for those who received the standard of care.

Actemra does not come without risks. In rheumatoid arthritis and other inflammatory disorders, the drug’s label carries a black box warning cautioning that serious opportunistic infections leading to hospitalization and death have been observed in patients treated with the drug. The FDA’s fact sheet for healthcare providers also flags these risks, cautioning that the drug should not be prescribed to those who have any active infection concurrent with the Covid-19 diagnosis. Gastrointestinal perforation and liver toxicity are other complications observed in Actemra’s Covid-19 clinical trials.

In other recent Covid-19 news:

•  Federal officials paused shipments of Eli Lilly’s Covid-19 antibody cocktail Friday. The Wall Street Journal reported that the action followed tests showing that bamlanivimab and etesevimab, the two antibodies comprising the drug, were not effective against the Gamma variant, first identified in Brazil, and the Beta variant, first identified in South Africa. In April, the FDA revoked emergency authorization of  bamlanivimab alone due to inefficacy against variants.

•  FDA approval of Gilead Sciences Covid-19 antiviral drug remdesivir (Veklury) was based on clinical trial data in about 2,000 patients. Real-world data from about 98,654 hospitalized patients were reported last week, lending additional support for the use of the drug.

•  Vir Biotechnology and GlaxoSmithKline reported positive Phase 3 data for an intramuscular injection formulation of its Covid-19 antibody drug, sotrovimab. An IV version of the drug was granted emergency use authorization last month.

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

•  Roche’s cobas Liat diagnostic system was granted emergency use authorization for PCR testing of both symptomatic and asymptomatic people at the point of care. The company said its system can produce results in about 20 minutes.

Photo: Giuseppe Aresu/Bloomberg, via Getty Images


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