21 Sep 2020
Posted in Pharma
Positive CHMP opinion on Baricitinib in atopic dermatitis positions it to take on Dupixent, says GlobalData
Eli Lilly’s baricitinib, marketed as Olumiant in rheumatoid arthritis, has received a recommendation of approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for moderate to severe adult atopic dermatitis (AD) patients, positioning the drug to take on Sanofi and Regeneron’s juggernaut Dupixent (dupilumab), says GlobalData, a leading data and analytics company.
Antoine Grey, Senior Immunology Analyst at GlobalData, comments: “Olumiant has the potential to be the first JAK inhibitor ever approved in Europe for atopic dermatitis. With a positive opinion from the CHMP, the likelihood of Olumiant being approved is very high, and would provide a novel treatment option for the largely under-served moderate-to-severe demographic, which currently only has access to immunomodulators and Dupixent.”
The CHMP opinion is now referred for action to the European Commission, which ultimately grants approval in the EU. Olumiant is expected to receive approval in AD ahead of other JAK inhibitor competitors such as Pfizer’s abrocitinib and AbbVie’s upadacitinib, which is marketed as Rinvoq in rheumatoid arthritis. Not only will the drug be first-in-class, but Olumiant is also expected to launch in Europe before new biologic options such as Lilly’s own lebrikizumab and Galderma’s nemolizumab.
Grey continues: “Olumiant’s timely launch will position it to rival Dupixent, the current gold standard of moderate-to-severe AD treatment. Indeed, should Olumiant receive approval, it will be in the same treatment line as Dupixent – reserved for patients who have not responded adequately to existing topical medications such as corticosteroids, calcineurin inhibitors and phosphodiesterase-4 (PDE-4) inhibitors. GlobalData expects Olumiant to generate sales of $1.3bn in 2028 in AD alone – although this is markedly less than Dupixent, which is predicted to garner 2028 sales of $5.3bn as it has been available in the AD market for three years now and dermatologists have become more comfortable prescribing the drug.”
With the expectation of becoming a blockbuster drug in AD, the future is bright for Olumiant. KOLs interviewed by GlobalData have mentioned that a subset of patients do not respond to the biologic. Olumiant will be perfectly placed to help these patients with limited treatment options, and they should feel reassured by the JAK inhibitor’s robust efficacy and safety profile.