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Rezolute's low blood sugar treatment gets FDA orphan drug status, aiding rare disease patients.
Rezolute, a biotech firm, received FDA's orphan-drug designation for its low blood sugar treatment, ersodetug, targeting a rare condition caused by tumors that trigger excessive insulin activity.
This designation offers seven years of market exclusivity and faster approval pathways, aiming to encourage treatments for rare diseases.
Rezolute plans to start a Phase 3 trial for ersodetug in 2025.
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El tratamiento bajo en azúcar en sangre de Rezolute obtiene el estatus de medicamentos huérfanos de la FDA, ayudando a los pacientes con enfermedades raras.