MHRA approves Amgen’s Tepezza for TED
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) yesterday approved Tepezza (teprotumumab (Tepezza). This is the first medicine to be licensed in the UK for adult patients with moderate to severe thyroid eye disease (TED), the Agency noted.
The new marketing authorization was granted to US biotech major Amgen (Nasdaq: AMGN), which reported $381 million in global sales for the first quarter of this year for the drug. Amgen acquired rights to Tepezza along with its $381 million buy of Horizon Therapeutics in 2023.
TED is an autoimmune condition where the immune system attacks the muscles and fat around the eyes. In TED, the immune system activates a protein called IGF-1R, causing inflammation and swelling in these tissues. Tepezza is designed to bind to IGF-1R to block its activation and signalling.
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