COVID-19 Brief: WHO Recommends Against Remdesivir, Roche Ramps Up to Produce Antibodies Treatment and More
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This morning, WHO issued a conditional recommendation against the use of remdesivir in hospitalized patients, regardless of the severity of the disease. The global health organization said there is currently no evidence that remdesivir improves survival and other outcomes in these patients.
The WHO made the recommendation hours after the U.S. Food and Drug Administration granted Emergency Use Authorization to a combination of Eli Lilly’s rheumatoid arthritis drug Olumiant and remdesivir as a treatment for hospitalized patients diagnosed with COVID-19 who require supplemental oxygen or ventilation. Remdesivir, sold under the trade name Veklury, was first granted EUA in May and later given full approval by the FDA in October.
The WHO guideline says there may be some small beneficial use for remdesivir, but did acknowledge there could be some benefit seen in individual patients.
The WHO recommendation is based on data from a study conducted by the health organization last month. The recommendation against remdesivir was based on data from four randomized trials including 7,333 people hospitalized with Covid-19. Data from the WHO SOLIDARITY study suggested remdesivir had no important effect on mortality, need for mechanical ventilation, time to clinical improvement and other patient-important outcomes. Although the WHO currently recommends against remdesivir as a COVID-19 treatment, its guideline development group said more research is needed, especially to provide higher certainty of evidence for specific groups of patients. They supported continued enrollment in trials evaluating remdesivir.
Gilead Sciences downplayed the WHO recommendations and said its antiviral is recognized as a “standard of care for the treatment of hospitalized patients with COVID-19 in guidelines from numerous credible national organizations, including the US National Institutes of Health and Infectious Diseases Society of America, Japan, UK and Germany.” Remdesivir has demonstrated its clinical benefits in multiple studies, the company said.
“We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19 in approximately 50 countries,” Gilead Sciences said in a statement.
The fight against COVID-19 continues to rage, even as Pfizer and BioNTech file for EUA of their mRNA-based vaccine, BNT162b2. The companies will file for EUA today in the United States, which will likely be quickly authorized. The companies also plan to file for authorization in Europe. The swift approval of the vaccine will spark a fast roll-out of the first batches that will likely be provided to front-line healthcare workers.
Moderna will also likely seek EUA for its mRNA-based vaccine within the next few weeks. According to Seeking Alpha, the European Union could grant conditional authorization to the Moderna medication in December. As more vaccines come on line, the EU is lining up to acquire hundreds of millions of doses from multiple companies, including Pfizer and BioNTech, AstraZeneca, Johnson & Johnson and CureVac. The EU has set aside about $10 billion to pay for the vaccines, Seeking Alpha reported.
Also in Europe, Ortho Clinical Diagnostics said its CE-marked Vitros SARS-CoV-2 antigen test can now detect SARS-CoV-2 infection in asymptomatic individuals. This could help curb the rising numbers of COVID cases in Europe, which is in the clutches of a second wave of infection. Ortho also manufactures two COVID-19 antibody tests -- Total and IgG -- which were granted EUA in April and achieved CE Mark in May
Roche Chief Executive Officer Severin Schwan is ramping up its capabilities to deliver COVID-19 antibody treatments, Seeking Alpha noted, citing a Bloomberg report. Roche partnered with Regeneron to bolster the manufacturing of the New York-based company’s antibody cocktail, REGN-COV2, which was used to treat President Donald Trump when he was diagnosed with COVID-19. Schwan said the green light could be given “very soon” for the EUA to distribute REGN-COV2. Like many treatments given authorization against COVID, there will be limited amounts available at first.
“We’re working hard to ramp up production as fast as we can,” Schwan said, according to the report. “No matter what, irrespective of other therapeutics, the demand for antibody cocktails will by far outstrip supply, so we have to make sure we target really the right patient groups.”