Orphalan Archives | Be Korea-savvy

Orphalan Announces FDA Acceptance for Filing of New Drug Application (NDA) for Trientine Tetrahydrochloride (TETA 4HCl) for the Treatment of Wilson’s Disease

Paris, France, Sept. 2 (Korea Bizwire) – Orphalan SA, a Company that identifies, develops and delivers worldwide therapies for orphan diseases, today announces that the US Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the first-line treatment of Wilson’s Disease. Wilson’s Disease is a rare [...]

Orphalan Announces Positive Top Line Data with Trientine Tetrahydrochloride for Maintenance Patients with Wilson’s Disease

Paris, France. June 25 (Korea Bizwire) — Orphalan SA is a company that identifies, develops and delivers innovative treatments to patients with rare diseases. Orphalan today announced positive top line results from a phase 3 head-to-head trial comparing d-Penicillamine with trientine tetrahydrochloride in Wilson’s Disease (WD). The phase 3 trial has been completed through an IND [...]