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AstraZeneca PLC on Friday said it received two recommendations for drug approvals in the EU, while a drug for blood disorder paroxysmal nocturnal haemoglobinuria met its primary endpoint in a phase three trial.
Nirsevimab, or beyfortus, which Astra develops with French partner Sanofi SA, targets respiratory syncytial virus, or RSV. The Committee for Medicinal Products for Human Use, or CHMP, of the EU's European Medicines Authority recommended the drug for EU approval for the broad newborn and infant population. Approval would mark the ‘first’ preventative option for that target group, AstraZeneca explained.
RSV is a common contagious virus affecting the lungs and breathing passages with no vaccines currently available for treatment. London-based pharmaceutical firm GSK PLC in June said it is close to developing the world's first RSV vaccine.
‘If approved, Beyfortus would be the first and only single-dose passive immunisation for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions,’ AstraZeneca said.
Meanwhile, AstraZeneca's Evusheld Covid antibody treatment has been recommended for marketing authorisation in the EU for adults with the virus at risk of progressing to severe disease. The company explained phase III treatment data showed reduced risk of severe Covid or death.
‘AstraZeneca anticipates that the European Commission will shortly complete its review of the CHMP positive opinion to determine whether to grant marketing authorisation for treatment of Covid in appropriate populations,’ it said.
Evusheld was granted marketing authorisation in the EU for the prevention of Covid earlier this year.
Finally, AstraZeneca said its phase three trial of Danicopan met its primary endpoint in blood disorder paroxysmal nocturnal haemoglobinuria, a disease with which red blood cells break apart prematurely.
The drug is trialled on people who have the blood disorder and experience clinically significant extravascular haemolysis, a destruction of red blood cells that can take place in the liver, spleen, bone, marrow and lymph nodes.
‘Danicopan plus Ultomiris or Soliris demonstrated superiority compared to placebo plus Ultomiris or Soliris for this specific patient population, with statistically significant and clinically meaningful improvements in haemoglobin levels, transfusion avoidance and functional assessment of chronic illness therapy fatigue scores from baseline,’ AstraZeneca said
AstraZeneca shares rose 1.3% to 10,260.00 pence each in London on Friday morning.
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