Teprotumumab accredited as first focused remedy for thyroid eye illness
The UK’s Medicines and Healthcare merchandise Regulatory Company (MHRA) has granted advertising authorisation for Amgen’s Tepezza (teprotumumab) as the primary licensed remedy for adults with moderate-to-severe thyroid eye illness (TED).
TED impacts round 50,000 individuals within the UK, inflicting eye bulging, double imaginative and prescient, ache and swelling, and considerably impacting sufferers’ high quality of life.
TED can result in anxiousness and melancholy, with sufferers usually fighting self-confidence and their capability to hold out day by day duties. Teprotumumab, an immunotherapy focusing on the insulin-like development factor-1 receptor (IGF-1R), is the primary remedy designed to deal with the underlying drivers of the illness somewhat than generalised irritation.
Dr Tony Patrikios, government medical director at Amgen UK & Eire mentioned: “The advertising authorisation for teprotumumab as the primary remedy particularly licensed for thyroid eye illness (TED) within the UK marks a step ahead for the affected person neighborhood.
He added: “TED can negatively have an effect on sufferers’ lives impacting imaginative and prescient, inflicting eye ache, making on a regular basis duties tough and inflicting a lack of self-confidence. This authorisation introduces a brand new various remedy possibility and reinforces Amgen’s dedication to supporting eligible sufferers with severe, underserved circumstances.”
The authorisation is backed by a number of medical research, together with the part 3 OPTIC trial, which confirmed that 83% of sufferers with energetic TED skilled a discount in proptosis (eye bulging) of at the very least 2mm in comparison with simply 10% within the placebo group.
Amgen is working with the Nationwide Institute for Well being and Care Excellence (NICE) to safe reimbursement for teprotumumab to make sure entry for all eligible sufferers within the UK.
Teprotumumab accredited as first focused remedy for thyroid eye illness
The UK’s Medicines and Healthcare merchandise Regulatory Company (MHRA) has granted advertising authorisation for Amgen’s Tepezza (teprotumumab) as the primary licensed remedy for adults with moderate-to-severe thyroid eye illness (TED).
TED impacts round 50,000 individuals within the UK, inflicting eye bulging, double imaginative and prescient, ache and swelling, and considerably impacting sufferers’ high quality of life.
TED can result in anxiousness and melancholy, with sufferers usually fighting self-confidence and their capability to hold out day by day duties. Teprotumumab, an immunotherapy focusing on the insulin-like development factor-1 receptor (IGF-1R), is the primary remedy designed to deal with the underlying drivers of the illness somewhat than generalised irritation.
Dr Tony Patrikios, government medical director at Amgen UK & Eire mentioned: “The advertising authorisation for teprotumumab as the primary remedy particularly licensed for thyroid eye illness (TED) within the UK marks a step ahead for the affected person neighborhood.
He added: “TED can negatively have an effect on sufferers’ lives impacting imaginative and prescient, inflicting eye ache, making on a regular basis duties tough and inflicting a lack of self-confidence. This authorisation introduces a brand new various remedy possibility and reinforces Amgen’s dedication to supporting eligible sufferers with severe, underserved circumstances.”
The authorisation is backed by a number of medical research, together with the part 3 OPTIC trial, which confirmed that 83% of sufferers with energetic TED skilled a discount in proptosis (eye bulging) of at the very least 2mm in comparison with simply 10% within the placebo group.
Amgen is working with the Nationwide Institute for Well being and Care Excellence (NICE) to safe reimbursement for teprotumumab to make sure entry for all eligible sufferers within the UK.
