Tepezza receives marketing authorisation from MHRA

(Image credit: ©Ralf/Adobe Stock)

Tepezza (teprotumumab) received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as the first therapy specifically licensed for the treatment of adult patients with moderate-to-severe thyroid eye disease (TED), announced Amgen.¹

“The marketing authorisation for teprotumumab as the first therapy specifically licensed for thyroid eye disease (TED) in the UK marks a step forward for the patient community,” said Dr Tony Patrikios, Executive Medical Director, Amgen UK & Ireland.

The marketing authorisation for teprotumumab is supported by multiple clinical studies – OPTIC phase 3 clinical trial, TED01RV phase 2 clinical study, HZNP-TEP-403 phase 4 clinical study, and the OPTIC-J phase 3 study.¹

OPTIC was a prospective, multi-centre randomized, doubled-blind, placebo-controlled phase 3 trial of the IGF-1R inhibitor teprotumumab or placebo in adults with Graves’ disease and active moderate-to-severe thyroid eye disease. It enrolled 83 patients between the ages of 18-80 years old and randomized 1:1 to receive 8 intravenous infusions of either teprotumumab or placebo.

The study demonstrated teprotumumab significantly improved the primary endpoint, proptosis (eye bulging) responder rate. The study showed that at 24 weeks, 83% of participants demonstrated a reduction of at least 2mm compared to baseline, compared to 10% of patients treated with placebo.¹

“TED can negatively affect patients’ lives impacting vision, causing eye pain, making everyday tasks difficult and causing a loss of self-confidence,” Dr Patrikios said. “This authorisation introduces a new alternative treatment option and reinforces Amgen’s commitment to supporting eligible patients with serious, underserved conditions.”

This progressive and potentially vision-threatening condition, approximately 50,000 people are living with TED in the UK. TED can cause eye bulging, double vision, eye pain, redness, and swelling.

“For adult patients living with thyroid eye disease, it can be challenging to receive a diagnosis and referral to specialist centers,” said Dr Jimmy Uddin, Consultant Ophthalmologist, Oculoplastic & Orbital Surgeon, Moorfields Eye Hospital and St George’s Hospital Medical School. “Teprotumumab offers eligible TED patients in the UK an important new treatment option.”

Reference:

1. Amgen’s TEPEZZA (teprotumumab) Granted Marketing Authorisation as the First Targeted Treatment Specifically for Adults With Moderate-to-severe Thyroid Eye Disease (TED) in the United Kingdom. BioSpace. Published May 8, 2025. Accessed May 8, 2025. https://www.biospace.com/press-releases/amgens-tepezza-teprotumumab-granted-marketing-authorisation-as-the-first-targeted-treatment-specifically-for-adults-with-moderate-to-severe-thyroid-eye-disease-ted-in-the-united-kingdom

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