The FDA on Thursday issued an emergency-use authorisation (EUA) to Eli Lilly and Incyte's oral JAK inhibitor Olumiant (baricitinib) for use in combination with Gilead Sciences' antiviral Veklury (remdesivir) to treat COVID-19 in hospitalised adults and paediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. Patrizia Cavazzoni, acting director of the FDA's Center for Drug Evaluation and Research, noted that this is the agency's first authorisation of a drug for COVID-19 that acts on the inflammation pathway.
The EUA was backed by data from the ACTT-2 trial, which was conducted by the US National Institute of Allergy and Infectious Diseases (NIAID). The study included about 1030 patients with moderate-to-severe COVID-19 who received Olumiant plus Veklury, or placebo and Veklury. The primary endpoint was time to recovery, defined as the patient no longer being hospitalised at day 29, or being well enough for discharge because they either do not need supplemental oxygen anymore or ongoing medical care in hospital.
Results showed that the combination significantly cut the median time to recovery from eight to seven days, compared to Veklury alone, reflecting a 12.5% improvement. Further, the odds of a patient's condition progressing to death or being ventilated at day 29 were also lower in the group given Olumiant and Veklury, as was the likelihood of clinical improvement at day 15. The FDA said the effects were statistically significant for all these endpoints.
Eli Lilly CEO David Ricks noted that the decision marks the second EUA for a Lilly therapy, following the recent authorisation of its neutralising antibody bamlanivimab in high-risk non-hospitalised individuals, "increasing the number of treatment options for COVID-19 patients at different stages of the disease." He added "this is an important milestone for hospitalised patients on oxygen, as [Olumiant] may help speed their recovery."
Olumiant is currently approved in the US and more than 70 other countries as a treatment for adults with moderately-to-severely active rheumatoid arthritis. Lilly said it was also recently approved in the EU for adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Meanwhile, Veklury became the first to receive full US approval for COVID-19 when the FDA cleared it last month for hospitalised patients aged 12 years and older and weighing at least 40 kg.
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