Covid-19 roundup: Eli Lilly's RA drug gets solo OK from FDA; Emergent gets greenlight to resume manufacturing at Bayview site
The FDA late Wednesday extended the EUA for Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) to be used as a solo treatment for Covid-19 in hospitalized adults and pediatric patients who need supplemental oxygen.
The oral drug was previously cleared in conjunction with Gilead’s remdesivir to treat those hospitalized with Covid-19.
In a Phase III study reported in April, Olumiant did not meet its primary endpoint. The drug failed to reach statistical significance for the difference in rate of patients needing non-invasive or invasive ventilation for the first time, or those who died after 4 weeks. But FDA said that the revised EUA for baricitinib was supported by data from that study, which showed a reduction in the proportion of patients who died after 4 weeks of follow-up compared to patients treated with the standard of care alone.
In May, Eli Lilly expanded its drug license with three generic drugmakers out of India, in an effort to curb the country’s second wave of Covid cases. Baricitinib was granted emergency use approval in India for the treatment of adult patients who need oxygen and are hospitalized.
Emergent resumes manufacturing at Bayview site
Roughly three months after manufacturing at Emergent BioSolutions’ Baltimore Bayview plant was halted, the FDA has given the company the go-ahead to resume production.
The production of J&J’s Covid-19 vaccine will resume — after the site shut down following a contamination incident that resulted in the discarding of millions of Covid-19 doses. A batch of drug substances intended for the AstraZeneca vaccine came in close proximity with a J&J batch, contaminating it.
“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” Emergent CEO Bob Kramer said in a statement. “We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone and we are grateful for the opportunity to help bring this global pandemic to an end. We’d like to thank our government partners as well as Johnson & Johnson for their support.”
Demand for J&J’s single-dose jab has waned in the US recently, but it remains a viable option for countries overseas that are lacking adequate doses, particularly those trying to inoculate people in rural areas.