Sentynl Therapeutics Inc. Announces FDA Approval of ZYCUBO® (copper histidinate) for Menkes Disease

Key facts

• ZYCUBO® is now the first and only therapy approved for the treatment of Menkes disease in the United States.
• Menkes disease is a rare X-linked recessive pediatric disease caused by mutations of the copper transporter ATP7A encoded by the ATP7A gene.
• ZYCUBO® is a subcutaneous injectable formulation of copper histidinate that restores copper homeostasis and maintains copper levels in patients with Menkes disease.
• Early treatment with ZYCUBO demonstrated a nearly 80% reduction in the risk of death compared to an untreated contemporaneous external control cohort.
• The most common adverse reactions (incidence ≥7%) included pneumonia, viral infection, respiratory failure, seizure, bacterial infection, hemorrhage, hypotension, vomiting, tachycardia, pyrexia, volume depletion, fracture, dyspnea, transaminases elevation, diarrhea, fungal infection, anemia, and local administration reaction.