As COVID-19 infections driven by the Delta variant continue to increase across the United States, the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization for Eli Lilly's monoclonal antibody to include treatment with or without Gilead Sciences’ remdesivir.
The previous EUA for baricitinib required the use of the antiviral drug. Under the expanded EUA, baricitinib can be used to treat COVID-19 in hospitalized adults and pediatric patients two years of age or older who need supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The FDA based its decision to expand the EUA based on data from the Phase III COV-BARRIER study that showed baricitinib-treated patients were less likely to proceed to mechanical ventilation than those on standard-of-care regimens. A pre-specified key secondary endpoint determined baricitinib, in addition to standard of care, meaningfully decreased the risk of death by 39%.
Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines, explained baricitinib combined with remdesivir has already proven to be an effective treatment option for COVID-19 patients. The expanded EUA provides an additional treatment option for treating physicians.
“Based on the increasing body of evidence, we are confident in the potential of baricitinib as an important treatment for the hospitalized COVID-19 patient population requiring supplemental oxygen,” Yuffa said in a statement.
Eli Lilly wasn’t the only COVID-related news announced today.
After a troubling spring, Emergent BioSolutions announced this morning that the FDA would allow it to resume manufacturing of the Johnson & Johnson COVID-19 vaccine bulk drug substance at its Bayview facility in Baltimore.
“This resumption of manufacturing follows extensive reviews by FDA, weeks of diligent work, and close coordination with J&J and FDA to execute on Emergent’s quality enhancement plan,” the company said this morning.
Earlier this year, Maryland-based Emergent BioSolutions was battered by manufacturing mishaps that led to the contamination of 15 million doses of the Johnson & Johnson vaccine. Those vaccine doses were destroyed as a result. Emergent CEO Robert Kramer expressed pride in how his company responded to the mishaps and worked with the FDA to correct the quality-control mistakes.
The U.S. Centers for Disease Control and Prevention (CDC) also announced new COVID guidance. Earlier this week, the CDC issued new guidance related to masks in high-risk areas, even among the vaccinated.
The latest change calls for vaccinated people to get a COVID test if they have come into contact with the virus. That is a shift from the previous guidance that said vaccinated individuals should only be tested if they began to show COVID symptoms, the Times reported. For those vaccinated individuals who are exposed, the CDC stated that they should get the test three to five days after exposure and take precautions to prevent potential spread.
Across the Atlantic, AstraZeneca CEO Pascal Soriot stated he was not sure a booster shot of the company’s COVID-19 vaccine would be necessary to maintain protection against the virus. In an interview with CNBC, he also mentioned not having a “precise answer” because of multiple dimensions to immunity.
The CEO pointed out that antibodies can diminish over time, but the T-cells generated by the vaccine provide protection against COVID-19. The T-cells offer durable, long-term protection. At this time, it’s unknown if the T-cells will diminish.
“With the technology we use, we have very high production of T-cells. We’re hoping we can have a durable vaccine that protects for a long period of time. So whether we will need a third booster or not is not clear yet, only time will tell,” Soriot said.
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