Request Demo
AstraZeneca adds to rare blood disease portfolio with world-first Voydeya approval in Japan
19 Jan 2024
Drug ApprovalPhase 3Clinical ResultBreakthrough TherapyPhase 2
AstraZeneca's newest addition to its PNH portfolio is under review with health authorities across the globe.
AstraZenecaer Novartis made its entry into the paroxysmal nocturnal haemoglobinuria (PNH) field, AstraZeneca’s newest contender Voydeya bolsters the company’s presence in the disease area with a world-first approval in Japan.
Voydeya (danicNovartis first-in-class oral factparoxysmal nocturnal haemoglobinuria (PNH)ese MiniAstraZenecalth, Labour and Welfare (MHLW) for use alongside a C5 inhibitor to treat PNH patients who have had an insufficient response to C5 inhibitors. It’s a new option for the 10% to 20% of patients with PNH who have experienced clinically significant extravascular haemolysis (EVH) after C5 inhibitor treatment, AZ notes.
Voydeya was designed as a potential add-on to AstraZeneca's established C5 inhibitor therapies Ultomoris or Soloris, which represent the current standard of caC5 inhibitorC5. In its ALPHA phasePNHtrial, Voydeya was able to change hemoglobin levelsC5 inhibitorsC5rom baseline to week 12 and meet secondary endpoints, including traPNHusion avoidance.extravascular haemolysis (EVH)C5 inhibitorC5
Long-term follow-up data from the study, whichAstraZenecay presented at C5 inhibitorC5cember, showed that the improvements in mean hemoglobin levels and absolute reticulocyte count levels held up throughVoydeyaks. Plus, 83% of patients didn’t need a blood transfusion after 12 weeks, while 78% of patients could say the same after 24 weeks.
“Voydeya, as add-on to standard-of-care, is a testament to our determination to address the needs of those impacted by clinically significant EVH without disruption to proven therapy,” Marc Dunoyer, CEO of AstraZeneca’s rare disease subsidiary Alexion, said in a press release.
Alexion has long dominated the PNH market with Ultomiris and Solaris. Competitors, such as Apellis’ Empaveli, have entered the ring recently, while Novartis’ factor B inhibitor Fabhalta (iptacopan) scored iAstraZenecaapproval in December.Alexion
Fabhalta meanwhile, carries an FDA breakthrough therapy designation in trare blood disordereived priority medicines status from the European Medicines Agency and is under review with “multiple global health authorities,” AstraZeneca noted in its release.
The company is also studying thFDAed as a potential monotherapy for geographic atrophy in a phase 2 trial.European Medicines AgencyAstraZeneca
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.