Eli Lilly’s Rheumatoid Arthritis Drug Gets Solo FDA Clearance; Emergent gets green light to resume manufacturing at Bayview site – Endpoints News


The FDA Wednesday night expanded EUA for Eli Lilly Olumiant rheumatoid arthritis medicine (baricitinib) to be used as a solo treatment for Covid-19 in hospitalized adults and pediatric patients who require supplemental oxygen.

The oral drug had previously been licensed in conjunction with Gilead’s remdesivir to treat people hospitalized with Covid-19.

In a phase III study reported in April, Olumiant did not meet its primary endpoint. The drug did not reach statistical significance for the difference in rates of patients requiring non-invasive or invasive ventilation for the first time, or those who died after 4 weeks. But the FDA said the revised EUA for baricitinib was backed by The data of this study, which showed a reduction in the proportion of patients who died after 4 weeks of follow-up compared to patients treated with standard care alone.

In May, Eli Lilly extended its drug license with three generic drug makers in India, with the aim of curbing the second wave of Covid cases in the country. Baricitinib has been granted emergency use authorization in India for the treatment of adult patients who require oxygen and are hospitalized.

Emergent resumes manufacturing at the Bayview site

Approximately three months after manufacturing at the Baltimore Bayview plant of Emerging BioSolutions was stopped, the FDA has given the company the green light to resume production.

J & J’s Covid-19 vaccine production will resume – after the site was closed following a contamination incident that resulted in the throw millions doses of Covid-19. A batch of drugs intended for the AstraZeneca vaccine came close to a batch of J&J, the contaminant.

“The American people should have high expectations of the partners their government chooses to help them prepare for disaster, and we have even higher expectations of ourselves,” said Emerg CEO Bob Kramer, in a press release. “We haven’t lived up to these lofty ambitions over the past few months, but resuming manufacturing is a key step and we are grateful for the opportunity to help end this global pandemic. We would like to thank our government partners as well as Johnson & Johnson for their support.

Demand for J & J’s single-dose vaccine has recently declined in the United States, but it remains a viable option for overseas countries that lack adequate doses, especially those attempting to vaccinate people in areas rural.


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