Teprotumumab

Teprotumumab is a fully human antibody developed by Genmab under our collaboration with Roche. Teprotumumab targets the Insulin-like Growth Factor-1 Receptor (IGF-1R), which is a well-validated target. Clinical development of teprotumumab in thyroid eye disease (Graves' orbitopathy) is being conducted by Horizon Pharma under a license from Roche. Teprotumumab has been granted Fast Track designation, Orphan Drug Designation and Breakthrough Therapy Designation for Graves' orbitopathy by the U.S. Food and Drug Administration (U.S. FDA).

Horizon Therapeutics submitted a Biologics License Application (BLA) to the U.S. FDA for teprotumumab for the treatment of active thyroid eye disease (TED).  Also Horizon, in partnership with the FDA, has developed an expanded access program for teprotumumab to make it available for people living with active TED who meet protocol criteria. The expanded access program will be available for a limited time while the FDA reviews Horizon’s BLA for teprotumumab.

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Thyroid eye disease (TED) is an autoimmune condition that is most commonly associated with hyperthyroidism, a disorder of the thyroid gland. Symptoms of TED include dry, watery, red eyes, double vision and other vision problems. Teprotumumab is in Phase III development to treat TED. For more information, visit clinicaltrials.gov.

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