Amid the global war on pandemic variants, the European Union has identified five COVID-19 therapeutics it will prioritize with the hope to authorize three by October.
Europe has selected four monoclonal antibody regimens—Eli Lilly's bamlanivimab/etesevimab combo, Celltrion’s regdanvimab, Regeneron and Roche’s casirivimab/ imdevimab cocktail and GlaxoSmithKline and Vir Biotechnology’s sotrovimab.
Also on the list is Eli Lilly’s baricitinib, a treatment already approved as Olumiant to treat rheumatoid arthritis and atopic dermatitis. The drug reduces the activity of the immune system and has been repurposed for COVID-19 patients on oxygen.
The effort is aimed at providing more regulatory flexibility with rolling reviews, conditional marketing authorizations and flexible labelling and packaging requirements. It also will allow for more scientific support from the European Medicines Agency and for the bloc to facilitate partnerships within the industry.
To that end, the EU will hold an industry "matchmaking event” on July 12 and 13. Officials aim to identify and address supply chain bottlenecks and make plans to immediately boost production for the drugs upon their potential approvals.
An apparent frontrunner is the antibody treatment from Regeneron. In February, the EMA issued a positive opinion on the cocktail for patients at risk of progressing to severe COVID-19. Earlier this month, the EU purchased 55,000 doses of the drug.
Lilly’s bamlanivimab and etesevimab combo was the first to win approval in the United States for COVID-19 patients at risk for progressing to a severe form of the disease. But with the cocktail showing weakness against COVID variants from Brazil and South Africa, the U.S. halted its use last week.
The sotrovimab antibody from GSK/Vir scored authorization for use in America last month, but the companies have yet to cut a deal with the U.S. to supply it.
Last October, Europe purchased 500,000 doses of Gilead's remdesivir for $1.2 billion. But a month later, the bloc suspended its use after the World Health Organization declared the drug ineffective for patients hospitalized with COViD-19.
The EU hopes to add more promising treatments to the portfolio, targeting 10 by the end of the year “subject to R&D outcomes,” it explained in a release.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.