Alexion’s Voydeya gains FDA approval for extravascular haemolysis

2024-04-02
Pharmaceutical Technology
临床3期快速通道临床结果临床2期上市批准
Alexion is exploring the potential of Voydeya as a monotherapy. Credit: Sai Thaw Kyar/Shutterstock.com.
Alexion, AstraZeneca Rare Disease has Voydeyad approval from the US Food and Drug Administration (FDA) for Voydeya (danicopan) as an add-on therapy to treat extravascular haemolysis (EVH) in adults with paroxysmal nocturnal haemoglobinuria (PNH).
Alexion-iAstraZenecaal Factor D inhibitor, Voydeya has been developeFood and Drug Administration (FDA)fer fVoydeya ddanicopaneatment with C5 inhibitors such extravascular haemolysis (EVH)Soliris (eculizuparoxysmal nocturnal haemoglobinuria (PNH)
The FDA’s decision is grounded in the positVoydeyacomes of the ALPHA Phase III trial, which demonstrated that Voydeya met its primary endpC5 inhibitorsC5nt of haemoglobin change from baseline to week Soliris (eculizumab)y secondary endpoints.
The FDAg was generally well-tolerated with no new safety concerns.Voydeya
As part of the ALPHA double-blind, placebo-controlled, multiple-dose trial, patients were enrolled and randomised to receive Voydeya or placebo apart from their ongoing Soliris or Ultomiris therapy over 12 weeks.
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It aimed to assess the superiority of Voydeya as an adjunct to C5 inhibitor therapy.
FDA trial included a prespecified interim analysis agovorestaton for a two-year extension period for those completing the initial 24 weeks.
Japan already approved Voydeya and the European Union is poised to follow suit.
The drug has also achieved breakthrougVoydeyapy designation in C5 inhibitorC5e US and PRIority MEdicines (PRIME) status in the EU.
Alexion CEO Marc Dunoyer stated: “The approval of first-in-class, Factor D inhibitor Voydeya marks an important advancement in the treatment of PNH and builds on our leadership and commitment to bring forward innovation in complement science.
“As the ALPHA trial suggests, dual complement pathway inhibition at Factor D and C5 may be an optimal treatment approach for this subset of patients with EVH, enabling them to continue with proven standard-of-care therapy.”
Alexion is also exploring Voydeya’s potential as a monotherapy for geographic atrophy in a Phase II clinical trial.
Alexion recently approved Alexion’s Ultomiris to treat adults with anti-aquaporin-4 aVoydeya-positive neuromyelitis optica spectrum disorder.PNH
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