AstraZeneca PLC (LSE:AZN) (AZ) shares were among the top risers on the FTSE 100 after the company received a triple dose of good news, including backing from the European Union drug regulator for its COVID-19 treatment.
Evusheld, a long-acting antibody combination, has been recommended for approval in the EU for those older than 12 years with Covid who do not require supplemental oxygen and who are at increased risk of progressing to a severe form of the disease.
This follows approval in August by Japan, the first country to move approval up from the previous status only as a preventative therapy for those with compromised immune systems who were not helped by vaccines.
AstraZeneca and ots partner Sanofi has also received EU endorsement for their experimental long-acting therapy Beyfortus for the prevention of respiratory syncytial virus (RSV), which is the most common cause of lower respiratory tract infections and a leading cause of hospitalisation of infants and a problem that leads to thousands of hospitalisations and deaths for the elderly.
Currently, there is one therapy for RSV on the market, while GSK PLC (LSE:GSK, NYSE:GSK) and Pfizer Inc (NYSE:PFE) have also made good progress with development of their treatments.
If Beyfortus receives marketing approval, it would be the first single-dose preventative therapy for RSV for infants.
"This positive CHMP opinion underscores Beyfortus' potential as a groundbreaking, first-in-class passive immunisation that could transform the medical community's approach to respiratory syncytial virus prevention in infants," said AZ vaccines and immune therapies chief Iskra Reic in a statement.
The third piece of news from AZ was that interim analysis of a Phase III trial evaluating its danicopan combination drug met its primary endpoint in potentially treating a rare and severe blood disorder.
Interim results showed "positive high-level results" in patients with paroxysmal nocturnal haemoglobinuria (PNH) who experience clinically significant extravascular haemolysis (EVH), with the primary endpoint being a change in haemoglobin from baseline at 12 weeks.
Key secondary endpoints were also met, including transfusion avoidance and change in functional assessment of chronic iIllness therapy (FACIT) fatigue score.
PNH is a rare and severe blood disorder characterised by the destruction of red blood cells, known as intravascular haemolysis.
AZ shares were up 2.4% to 10,376p in morning trade on Friday.