Horizon’s Tepezza becomes first and only FDA-approved drug for thyroid eye disorder

pharmafile | January 22, 2020 | News story | Research and Development FDA, Horizon Therapeutics, Tepezza, pharma 

Horizon Therapeutics has announced that its IGF-1R inhibitor Tepezza (teprotumumab-trbw) has become the first and only therapy approved by the FDA for the treatment of thyroid eye disease (TED).

The drug was reviewed under the US regulator’s Priority Review pathway and provides a new treatment to tackle the rare, progressive autoimmune disease which can, in some cases, lead to vision loss. The condition is characterised by bulging of the eyes, blurred or double vision, inflammation and pain.

The approval decision was reached based on Phase 2 and 3 data which showed that 82.9% of patients taking Tepezza saw an improvement in bulging of the eyes compared to 9.5% with placebo without deterioration in the fellow eye after 24 weeks of treatment.

Furthermore, 67.9% of Tepezza patients saw a change from baseline by at least one grade in double vision compared with 28.6% with placebo after 24 weeks, while 53% of Tepezza patients achieved complete resolution of double vision compared to 25% of placebo patients.

“Today is a great day for people living with Thyroid Eye Disease, a rare, vision-threatening disease that previously had no FDA-approved treatment options,” said Timothy Walbert, Chairman, President and CEO of Horizon. “The TED community has gone far too long without an FDA-approved therapy, and we are grateful to the people living with TED and physicians who partnered with us on the clinical development programme that led to today’s approval of TEPEZZA. This also marks the early approval of Horizon’s first Biologics License Application – a key step in our evolution to an innovation-focused biopharma company, developing new medicines for debilitating diseases with few or no treatment options.”

Matt Fellows

Related Content

FDA approves ANDA of 20mg generic Nitisinone capsules

Analog Pharma and Dipharma have announced that the US Food and Drug Administration (FDA) has …

FDA approves Pfizer’s RSV vaccine for older adults

Global pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has …

Bristol Myers Squibb’s NDA accepted by FDA

Global pharmaceutical company Bristol Myers Squibb (BMS) has announced that its New Drug Application (NDA) …

Latest content