Europe’s medicines regulator has backed using AstraZeneca’s AZN.L preventative COVID-19 drug as a treatment for the disease and also endorsed its therapy against a major cause of pneumonia.
The regulator’s recommendations are usually followed by the European Commission when it takes a final decision on drug approvals.
AstraZeneca said on Friday the European Medicines Agency (EMA) had backed Evusheld as a treatment for adults and adolescents with COVID who do not need supplemental oxygen and who are at increased risk of their disease worsening.
The antibody cocktail was previously only approved as a preventative treatment for people with compromised immune systems who see little or no benefit from vaccines.
The EMA also endorsed Beyfortus for the prevention of RSV lower respiratory tract disease in infants.
RSV is a leading cause of pneumonia in toddlers and the elderly, but the complex molecular structure of the virus and safety concerns have stymied efforts to develop a vaccine since the virus was first discovered in 1956.
AstraZeneca is developing Beyfortus, chemically called nirsevimab, along with Sanofi SASY.PA. Others in the race to get an RSV vaccine or therapy approved include Pfizer PFE.N, J&J JNJ.N, Moderna MRNA.O and GSK GSK.L.
In July, the company forecast prescriptions of the COVID therapy would help drive group sales growth of more than 20% this year. The long-acting antibody treatment, launched in December, generated $445 million of sales in the second quarter.