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 eye socket and CAS in active TED, with a smaller effect (−1.5 mm) in chronic cases
- Tepezza (mAb) blocks autoimmune activation of orbital fibroblasts to help prevent and slow TED progression
Ref: Ema | Image: Amgen | Press Release
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