By Colin Kellaher
Eli Lilly & Co. on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive scientific opinion for the company's antibody-based Covid-19 drugs aimed at helping people at high risk of severe disease avoid hospitalization.
The Indianapolis drugmaker said the opinion covers its monoclonal antibody bamlanivimab alone and in combination with one named etesevimab for the treatment of confirmed Covid-19 in patients ages 12 years and older who don't need supplemental oxygen and are at high risk of progressing to severe Covid-19.
Monoclonal antibodies are engineered proteins that mimic the immune system's ability to fight off viruses.
Eli Lilly said European Union member states can consider the opinion when making decisions on use of the therapies at a national level before a formal marketing authorization is issued by the European Commission.
The company noted that other countries look to CHMP advice to support their own reviews.
"We hope this opinion will accelerate those reviews and authorizations, particularly in low- and middle-income countries, where Lilly is prepared to provide doses at greatly reduced costs or free of charge," the company said.
The Food and Drug Administration has granted emergency-use authorization to bamlanivimab and the bamlanivimab/etesevimab combination.
Write to Colin Kellaher at firstname.lastname@example.org
(END) Dow Jones Newswires