US FDA awards Supplemental Orphan Drug Designation to SurVaxM to now include treatment of Malignant Glioma
30 May 2024
Orphan DrugPhase 2ImmunotherapyVaccine
The U.S. Food and Drug Administration (FDA) has granted supplemental orphan-drug designation (ODD) to SurVaxM for use in patients with malignant gliomas.
New orphan designation broadens the patient population for potential use of SurVaxM to include forms of adult and pediatric malignant gliomas other than glioblastoma.
ODD expands market exclusivity of SurVaxM beyond its previous designation of adult glioblastoma.
BUFFALO, N.Y., May 30, 2024 /PRNewswire/ -- MimiVax Inc, a clinical-stage biotechnology company developing immunotherapeutics for cancer and autoimmune diseases, today announced that the United States Food and Drug Administration (FDA) has awarded a supplemental orphan drug designation to MimiVax's SurVaxM vaccine to now include malignant glioma. Currently, SurVaxM vaccine is being studied as a treatment for newly diagnosed glioblastoma (nGBM) in a phase 2b randomized clinical study (the SURVIVE trial) which will assess the efficacy of SurVaxM in a large patient population with nGBM. This supplemental orphan drug designation greatly expands the potential for SurVaxM's use in other forms of pediatric and adult malignant gliomas. An orphan drug designation plays a critical role in encouraging the development of treatments for rare diseases, ultimately improving the lives of patients who might otherwise have few or no treatment options.
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Source: PRNewswire
(PRNewsfoto/MimiVax, LLC)
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