By Fineline Cube 
US biotech Amgen (NASDAQ: AMGN) announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted market approval for its drug Tepezza (teprotumumab). This approval allows the drug to be used in treating adult patients with moderate-to-severe Thyroid Eye Disease (TED).
Mechanism of Action
Tepezza is the world’s first approved immunotherapy targeting the insulin-like growth factor-1 receptor (IGF-1R), which is believed to play a crucial role in the development of TED.
Clinical Trial Results
In the pivotal Phase III OPTIC study, which supported the approval, 83% (34/41) of patients with active moderate-to-severe TED treated with teprotumumab showed a reduction in proptosis (eye bulging) of at least 2mm. This compares to just 10% (4/42) of patients treated with a placebo.
Reimbursement Efforts
Amgen will collaborate with the National Institute for Health and Care Excellence (NICE) to seek reimbursement for teprotumumab for all eligible patients.-Fineline Info & Tech