AstraZeneca PLC (LSE:AZN)'s application for Evusheld, an antibody-based Coronavirus (COVID-19) therapy is being reviewed by the European Medicines Agency, in an important step towards approval by the region.
The EMA's Committee for Medicinal Products for Human Use (CHMP) has, however, not set a deadline for concluding the review, a Reuters report said, citing the drug regulator.
The antibody cocktail Evusheld, developed by AstraZeneca, was approved in the United States in December for people aged 12 and older with weak immune systems, or those who have suffered severe side effects from a coronavirus vaccination in the past.
In October 2021, CHMP began reviewing the data on the antibody cocktail.
The COVID-19 therapy is monoclonal antibodies (MABs)-based, which treats rather than prevents illnesses.
The US government is expected to run out of MAB supplies by late May and will scale back plans to get more unless Congress provides more funding, the White House said.
Infections from COVID-19 are still soaring in some parts of the world, including Europe, with Germany reporting a record high seven-day incidence on Tuesday, just days before the planned easing of restrictions.
COVID-19 infections jumped steeply in China on Tuesday as well, with new cases more than doubling from a day earlier. According to official data, China reported 1,860 new cases of local symptomatic COVID-19 on Tuesday, the fourth day in a row cases have risen by more than a 1,000.
A fourth booster dose of the COVID-19 vaccine for 65-year-olds and older has been requested by Pfizer and its German partner BioNTech, who have sought an emergency use authorisation to US regulators.