AstraZeneca on Monday announced further support from regulators for its first-in-class blood disease treatment.
The Cambridge-based pharmaceutical company said that the European Medicine Agency’s Committee for Medicinal Products for Human Use had recommended Voydeya for marketing authorisation in the European Union.
Voydeya is an oral, factor-D inhibitor used to treat paroxysmal nocturnal haemoglobinuria patients who suffer from extravascular haemolysis.
PNH is a blood disorder characterised by the destruction of red blood cells inside blood vessels, as well as white blood cell and platelet activation which can lead to potentially fatal organ damage. When using certain treatments, around 10% to 20% of patients suffer from extravascular haemolysis, which involves the destruction of red blood cells outside blood vessels.
The EMA decision was based on phase-III trials of the drug, the results of which were published in June, and which demonstrated a ‘statistically significant’ increase in haemoglobin compared to the placebo group.
Voydeya has already been granted ‘breakthrough therapy’ designation by the US Food & Drug Administration, and ‘priority medicine’ status by the EMA.
Shares in AstraZeneca were up 1.3% at 10,348.95 pence each in London on Monday morning.
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