Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-trbw) in Active Thyroid Eye Disease

Shots: Amgen has reported topline P-III results assessing Tepezza (SC, Q2W × 12) vs PBO dosed via an on-body injector in pts with mod. to sev. active Thyroid Eye Disease (TED) The trial met its 1EP, showing a 76.7% vs 19.6% proptosis response rate, with 3.17 vs 0.80 mm mean proptosis reduction (key 2EP) at 24wks.…

ByRidhi RastogiApril 7, 2026

Amgen Reports the MHRA’s Approval of Tepezza to Treat Thyroid Eye Disease

Shots: UK’s MHRA has approved Tepezza (teprotumumab) for the treatment of adult pts with mod. to sev. thyroid eye disease (TED) Approval was based on extensive clinical data incl. P-III (OPTIC) trial (n=83), P-II (TED01RV) trial (n=88), P-IV (HZNP-TEP-403) trial (n=62) & P-III (OPTIC-J) trial in Japan (n=54) OPTIC trial showed that 83% (34/41) of…

ByRidhi RastogiMay 8, 2025

The CHMP Adopts Positive Opinion on Amgen’s Tepezza to Treat Thyroid Eye Disease

Shots: The EMA has recommended marketing authorization for Tepezza (teprotumumab) for adults with mod. to sev. thyroid eye disease The opinion was based on three randomized, PBO-controlled studies in 225 active and 62 chronic TED pts. After 24 wks., Tepezza significantly reduced eye protrusion (−2 to −2.3 mm) in protrusion of the eyeball from the…

ByDipanshu DixitApril 25, 2025

Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-trbw) in Active Thyroid Eye Disease

Amgen Reports the MHRA’s Approval of Tepezza to Treat Thyroid Eye Disease

The CHMP Adopts Positive Opinion on Amgen’s Tepezza to Treat Thyroid Eye Disease

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