It's not just the antibodies: Eli Lilly burnishes its second EUA in play with new Covid-19 data on Olumiant plus remdesivir
Eli Lilly is on a roll.
Days after reporting positive data for its Covid-19 neutralizing antibodies, the pharma giant said adding its JAK inhibitor Olumiant to Gilead’s remdesivir cut the risk of death — although the result wasn’t statistically significant.
New data from ACTT-2, an adoptive treatment trial conducted by the NIH, are in line with what investigators disclosed a month ago regarding improvements in time to recovery.
Lilly said it’s talking to regulators about a potential EUA covering adult patients hospitalized for the infection. ACTT-1, the predecessor trial that established remdesivir as a standard treatment in the hospital setting, also paved the way for its authorization.
Here’s what we already know: The combination of Olumiant, or baricitinib, with remdesivir helped patients recover faster than remdesivir alone, cutting the median time to recovery by about one day. Recovery was defined by meeting the criteria for hospital discharge.
Lilly has now revealed that the reduction was from 8 to 7 days (p = 0.04), and that the benefits are most pronounced among patients requiring supplemental oxygen or non-invasive ventilation at baseline.
Presenting at a special conference, NIAID associate director for clinical research John Beigel also discussed a secondary endpoint for the first time. Patients taking Olumiant/remdesivir were 30% more likely to improve in clinical status after 15 days than those only given remdesivir.
Probing into mortality through day 29, he observed a numerical decrease from 7.8% to 5.1%, but the p-value failed to hit the bar at 0.09.
The full analysis is still ongoing and a peer reviewed manuscript has yet to materialize. But the results mark further validation for its hypothesis that JAK is the right target to hit in order to dampen dangerous immune responses caused by SARS-CoV-2 while the IL-6 repurposing theory bites the dust (although Roche appears to be holding out hope).
The FDA’s actions and physician response here will also test how receptive regulators and doctors are to incremental benefits offered by add-on drugs.
In the ACTT-1 trial, remdesivir was shown to have sped up recovery by 4 days compared to best supportive care. There was a 3-percentage-point improvement in mortality that was statistically insignificant. Although Gilead later released more data from single-arm studies, skeptics remained leery of the antiviral drug’s real effect.
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