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.

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