LONDON (dpa-AFX) - AstraZeneca PLC (AZN.L) Tuesday said its Voydeya has been approved in Canada as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have residual hemolytic anemia due to extravascular hemolysis (EVH).
PNH is a rare, progressive blood disorder, characterized by red blood cell destruction within blood vessels and white blood cell and platelet activation, which can result in blood clots.
The approval was based on the results from ALPHA Phase III trial, in which Voydeya as an add-on to standard of care ravulizumab or eculizumab, showed statistically significant and clinically meaningful increase in haemoglobin levels and maintained disease control in patients with PNH who experience clinically significant EVH compared to those who were treated with placebo plus standard of care.
Voydeya has been approved in the US, EU and Japan, and regulatory reviews are ongoing in additional countries.
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