EU and Lilly agreement for antibody therapy in patients with covid mutations

Agreement on the supply 220,000 doses of antibody therapy in confirmed patients aged 12 years old and above, signed by Lilly Pharmaceutical Company with the European Commission.

This is the treatment of confirmed disease COVID-19 in patients aged 12 years and older who do not require supplemental oxygen and who are at increased risk of ICU admission.

The combination bamlanivimab and etesevimab antibodies is already available through emergency administration procedures in 15 countries around the world for the treatment of COVID-19.

It has not yet received official marketing authorisation in the European Union and has not been approved by the FDA. However, it has received emergency use permit in the United States, for as long as circumstances exist which justify the temporary licence under the relevant legislation, unless the licence is terminated or revoked earlier.

With the agreement signed, all European Union (EU) countries will have access to the treatment and the European Economic Area (EEA) and will be able to buy the products directly from Lilly, following a national authorisation for emergency use or a marketing authorisation at European level.

The quantities purchased may vary according to local needs as determined by the participating countries.

This came as a consequence of the positive scientific opinion under Article 5(3) of Regulation 726/2004 issued by the Committee for Medicinal Products for Human Use (CHMP)) of the European Medicines Agency (EMA) last March, which supports the use of these antibodies as a treatment for COVID- 19 in patients aged 12 yearsn and above.

The CHMP's scientific opinion supports national decision-making in EU Member States on the use of therapies before a formal marketing authorisation is granted, during a public health emergency.

According to preclinical data from Lilly Laboratories, bamlanivimab and etesevimab antibodies administered together retain the ability to neutralise the mutant strains of the virus currently circulating in many countries, including the Delta mutants and Alpha.

Today, due to the high infectivity of the Delta mutation, it is estimated that more than 95% of new COVID-19 infections in the EU/EEA are caused by this mutation.