Orphalan Cuvrior Earned Earlier Use With Head-To-Head Trial Against Frontline Wilson’s Disease Drug
French orphan specialist developed new assay for primary endpoint to show non-inferiority of its room temperature-stable salt of trientine, earning a broader FDA approval than generically available second-line trientine products.
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Alexion/AstraZeneca has announced positive top-line results from the Phase III study of ALXN1840 in patients with the rare genetic disorder, Wilson disease, including in patients already on standard-of-care therapies. The compound is ahead of two candidate gene therapies from other companies at early-stage clinical development.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Novel agents approved under Real-Time Oncology Review posted a median time to approval of seven months, our Pink Sheet RTOR infographic shows, while other RTOR applications had a median 4.5 month approval time.