AstraZeneca’s Voydeya recommended for approval in EU by CHMP
Betsy Goodfellow | February 29, 2024 | News story | Medical Communications | AstraZeneca, CHMP, EMA, Haematology, Voydeya
AstraZeneca has announced that Voydeya (danicopan) has been recommended for marketing authorisation in the European Union (EU) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The drug is a first-in-class oral, Factor D inhibitor developed as an add-on to standard-of-care Ultomiris (ravulizumab) or Soliris (eculizumab) for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH). This drug combination is intended to ‘address the needs of the approximately 10-20% of patients with PNH who experience clinically significant extravascular haemolysis (EVH) while treated with a C5 inhibitor’, according to the company’s press release.
This positive recommendation follows data from the phase 3 ALPHA trial which was published in The Lancet Oncology. This trial assessed the safety and efficacy of the drug as an add-on to standard of care in PNH patients who experienced clinically significant EVH. Results demonstrated that it met its primary endpoint of change in haemoglobin from baseline to week 12, as well as meeting all secondary endpoints such as transfusion avoidance and change in Functional Assessment of Chronic Illness Therapy – Fatigue score.
Marc Dunoyer, chief executive officer of Alexion, a subsidiary of AstraZeneca, commented: “Today’s positive CHMP recommendation recognises the promise of Voydeya as an add-on to standard-of-care to address signs and symptoms of clinically significant EVH for this small subset of patients. As we saw in the pivotal ALPHA phase 3 trial, dual complement pathway inhibition at Factor D and C5 may be an optimal treatment approach for these patients.”
Betsy Goodfellow
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
NICE recommends Benralizumab for Rare Form of Vasculitis
The National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca’s benralizumab (Fasenra) as …
NICE approves AstraZeneca’s dual immunotherapy for advanced liver cancer
AstraZeneca has received a positive recommendation from the National Institute for Health and Care Excellence …
