Britain's Medicines and Healthcare products Regulatory Agency (MHRA) has approved AstraZeneca Plc's (NASDAQ:AZN) antibody-based COVID-19 treatment to prevent infections in adults with poor immune response.
The approval covers Evusheld for adults who are not currently infected (or know exposure to) and for whom vaccination is not recommended.
Tixagevimab co-packaged with cilgavimab, formerly known as AZD7442, combines two monoclonal antibodies given as separate sequential intramuscular (IM) injections.
The therapy cut the risk of developing symptomatic COVID-19 by 77% in trials, with protection lasting for at least six months after a single dose.
Evusheld has also been shown to save lives and prevent disease progression when given within a week of first symptoms.
Evusheld is under a European review and has been authorized in the U.S. to prevent COVID-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines.
The recommended dosage is 300 mg of the antibody combination, but a higher dose of 600 mg may be more appropriate for some SARS-CoV-2 variants.
Price Action: AZN shares are down 0.05% at $61.93 during the premarket session on the last check Thursday.