FDA gives emergency approval to Eli Lilly’s arthritis drug paired with remdesivir for treating hospitalized coronavirus patients – after WHO warns NOT to use the antiviral
- FDA issued emergency use authorization for the use of Eli Lilly’s rheumatoid arthritis drug baricitinib in combination with remdesiver to treat COVID-19
- The approval, made Thursday, comes as World Health Organization officials said remdesivir, Gilead’s antiviral, does not help hospitalized patients
- U.S. regulators approved the combination for treating patients ages two and older who are hospitalized for COVID-19 and need oxygen support or ventilation
- Approval was based on a trial that found patients treated with the combination recovered a day faster than those who go only remdesivir
- Death risks were a third lower among patients treated with the arthritis drug and remdesivir compared to the antiviral alone
Food and Drug Administration (FDA) regulators issued emergency use authorization for a new COVID-19 treatment using an arthritis drug in combination with the antiviral remdesivir on Thursday.
The emergency approval of baricitinib is the second this month for Eli Lilly, whose coronavirus antibody treatment was given the same status on November 9.
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Baricitinib is a rheumatoid arthritis drug that was tested with remdesivir in the hopes it could add anti-inflammatory effects to the antiviral’s benefits.
Clinical trials found that hospitalized patients who needed oxygen support or ventilators and were treated with the combination were a third less likely to die, compared those who were treated with remdesivir alone.
Those who got the drug combination also recovered from coronavirus about a day faster than did those who got only remdesivir.
But the announcement comes at a perplexing moment for remdesivir. It’s one of the FDA-authorized treatments for COVID-19 in the U.S. but the World Health Organization also warned on Friday that the drug should not be used to treat hospitalized coronavirus patients.
Eli Lilly’s arthritis drug baricitinib, combined with the antiviral remdesivir, was given emergency approval for treating hospitalized coronavirus patients on Thursday
A National Institutes of Health (NIH) study found that remdesivir reduced the risk of death for hospitalized coronavirus patients by as much as 30 percent and sped up recovery times.
But in the WHO’s trials, it has not proven as effective, showing no sign of reducing mortality and leading the international agency to drop the drug from its list of potential treatments.
Remdesivir was originally developed by Gilead as an antiviral against Ebola, but failed in trials.
It found a second life when it was tested for suppressing viral load of coronavirus.
Regardless of whether the NIH or WHO trial is correct, the drug was never designed to directly impact inflammation levels in COVID-19 patients.
Out-of-control immune responses in coronavirus patients’ bodies lead to inflammation that often ends up being the real killer.
So scientists began testing whether the apparent benefits of remdesivir could be augmented by other drugs that fight inflammation.
Therapeutics for conditions – especially autoimmune ones – characterized by abnormal inflammation were the obvious top candidates.
Researchers got to work testing drugs for conditions like lupus and rheumatoid arthritis.
It comes as the World Health Organization warns that remdesivir does not improve survival odds for hospitalized COVID-19 patients
In trials, patients who were in hospitals and needed help breathing and got baricitinib and remdesivir recovered in seven days on average.
Patients who got remdesivir alone were hospitalized for eight days.
Within 29 days of hospitalization, 23 percent of the baricitinib group either had to be put on ventilators or died, compared to 28 percent in the remdesivir only group.
More than seven percent of the remdesivir alone group died by the end of the trial.
Only 4.7 percent of the patients who got baricitinib and the antiviral died.
‘The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” said Dr Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research.
‘Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients.’