Voydeya PIL update via Article 61.3  (Ref. EMA/N/0000284950) to correct local Marketing Authorization Holder for Spain.

Voydeya SmPC update following approval of group type II variation EMEA/H/C/005517/II/0004/G, granted by EMA on 23 January 2025:

• Type II (C.I.4) Submission of Final clinical study report ALXN2040-PNH-301 (a Phase 3 Study of Danicopan as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in patients with PNH who have clinically evident Extravascular Haemolysis).
• Type II (C.I.13) – Submission of the final report from study ACH471-101 (a multicenter, open-label, multiple dose Phase 2 study to assess efficacy, safety, and tolerability of add-on danicopan to background eculizumab therapy in adult participants with PNH).

Updated SmPC sections:

Section 2. Qualitative and quantitative composition - correction of excipient statement for lactose monohydrate.

Section 4.8 Undesirable effects - Updated frequency of adverse events following end of trial, removal of Northern Ireland AE reporting details in alignment with Windsor Framework implementation.

Section 5.1 Pharmacodynamic properties - Updated information following end of trial.