CHMP positive for Voydeya (danicopan) as add-on therapy to ravulizumab or eculizumab for the treatment of residual haemolytic anaemia in adult patients with paroxysmal nocturnal haemoglobinuria.-Alexion/AstraZeneca
On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Voydeya, intended as add-on therapy to ravulizumab or eculizumab for the treatment of residual haemolytic anaemia in adult patients with paroxysmal nocturnal haemoglobinuria (PNH)
The applicant for this medicinal product is Alexion Europe. Voydeya will be available as 50 mg and 100 mg film-coated tablets. The active substance of Voydeya is Danicopan, a complement inhibitor (ATC code: L04AJ09) which reversibly binds to factor D to prevent alternative pathway-mediated haemolysis and deposition of complement C3 proteins on red blood cells, thereby helping to relieve the symptoms of PNH.
The benefit of Voydeya, when added to C5-inhibitor treatment, is its ability to prevent haemolysis and increase haemoglobin levels, as seen in a phase III randomised, placebo-controlled trial in patients with PNH and residual haemolytic anaemia. The most common side effects are pyrexia, headache, increased hepatic enzyme levels and pain in the extremities.
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