What is it prescribed for?
VOYDEYA, approved on April 1, 2024, is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria.
What is the name of the drug and what does it do?
Voydeya (pronounced voy-DAY-uh), (generic name: danicopan), is a medication indicated as an add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). Voydeya is designed to address the breakdown of red blood cells that takes place outside of blood vessels.
How does it work?
Voydeya is a complement factor D inhibitor. Complement factor D is a part of the immune system that plays a key role in the alternative pathway of the complement system, which contributes to the destruction of red blood cells in PNH. By inhibiting factor D, Voydeya helps reduce the destruction of red blood cells, alleviating the symptoms of EVH.
What did the research discover?
Clinical trials, specifically Study ALXN2040-PNH-301, have shown that Voydeya, when used in combination with ravulizumab or eculizumab, significantly improves hemoglobin levels in patients with PNH. In the study, patients receiving Voydeya exhibited a mean increase in hemoglobin levels of 2.9 g/dL compared to 0.5 g/dL in the placebo group. Additionally, 59.5% of patients treated with Voydeya achieved a hemoglobin increase of at least 2 g/dL without the need for transfusions, compared to none in the placebo group.
What are some of the side effects?
- Headache
- Vomiting
- Pyrexia (fever)
- Increased alanine aminotransferase (ALT)
- Hypertension
- Pain in extremities
What are the dosage recommendations and how is it prescribed?
Voydeya is administered orally with the recommended starting dosage being 150 mg three times a day. This dose can be increased to 200 mg three times a day based on clinical response, particularly if hemoglobin levels have not increased by more than 2 g/dL after 4 weeks of therapy, or if the patient required a transfusion during the previous 4 weeks.
It is crucial that patients are vaccinated against encapsulated bacteria at least 2 weeks prior to starting Voydeya, and they must enroll in the Voydeya REMS (Risk Evaluation and Mitigation Strategy) program due to the risk of serious infections.
Source:
Alexion Pharmaceuticals, Inc. Voydeya (danicopan) tablets, for oral use. Prescribing Information. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218037s000lbl.pdf
