India Panel No-Go For Lilly’s Antibody In COVID-19
More Data Required?
India expert panel decides not to back Lilly’s bamlanivimab as a COVID-19 therapy, at least for now, under the accelerated approval route and without local trials, but the US firm is still pursuing an authorization request. Physicians underscore the need for more data on important patient outcomes for the antibody product.
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Lilly’s anticancer abemaciclib and rheumatoid arthritis drug baricitinib, which has received a US EUA for COVID-19, have become targets of challenger Natco in India. The US giant says it's working closely with India’s health ministry to ensure access to patients who need its innovative therapies, amid indications Natco may be weighing plans to seek a voluntary license for baricitinib.
Most of Lilly’s 2021 gains will come from its newer products, but sales of COVID-19 treatments added $500m to the company’s 2020 revenue guidance and may total $1bn-$2bn next year.
As distribution of Regeneron’s monoclonal antibody treatment for coronavirus begins, OWS officials worry about provider confusion with Lilly’s product due to differences in preparation and administration.