09 May 2020
Posted in Pharma
Eli Lilly becomes the latest large pharma to join the fight against COVID-19
In April, Eli Lilly joined the fight in treating COVID-19 with an announcement that it had agreed to study Olumiant (baricitinib) as an arm in NIAID’s Adaptive COVID-19 Treatment Trial (NCT04280705). However, Olumiant is not without its share of risks and providers will still need to evaluate the risk-benefit ratio for this particular immunomodulatory agent when treating this patient population, says GlobalData, a leading data and analytics company.
Tiffany Chan, Immunology Analyst at GlobalData, notes: “Studying Olumiant may seem counterintuitive, but the interest in Olumiant may be two-fold. News about the clinical trial comes after an article was published in the Lancet in early February 2020, in which researchers at the Imperial College London used artificial intelligence (AI) to determine which marketed drugs may be useful in treating the disease. Researchers hypothesize that Olumiant may inhibit viral infections by binding and inhibiting a protein called AP2-associated protein kinase 1 (AAK1), which would reduce viral entry into cells and subsequent inflammation.
“Using an immunomodulatory agent to treat COVID-19 may also help to limit the inflammatory damage caused by a ‘cytokine storm’, which ultimately results in more severe disease and worse prognosis. The cytokine storm is similar to the progression of sepsis, a condition in which immunosuppressants have been theorized to be beneficial.”
If proven efficacious, the use of an already approved agent will bypass some regulatory and manufacturing hurdles an experimental drug might face. Eli Lilly will not need to put Olumiant through the same battery of early-stage safety and tolerability trials that a pipeline drug would require to gain approval. However, label expansion still requires a safety assessment for use within the new disease or patient population it is seeking approval for, in this case, for COVID-19 patients. Furthermore, marketing and manufacturing infrastructure for Olumiant is already in place to allow for relatively quick distribution.
Chan concludes: “In the realm of rheumatology, JAK inhibitors have had a checkered past due to safety concerns. All JAK inhibitors currently approved by the FDA have the agency’s strictest “black box” safety warnings. Olumiant in particular currently has warnings for increased risk of serious infections, tuberculosis, lymphoma and thrombosis.”