FDA approves the first treatment for thyroid eye disease (TED)

Thyroid eye disease (TED) is a rare and debilitating autoimmune disease. It causes the muscles and soft tissues within the eye socket to swell. This pushes the eyeball forward and causes various eye symptoms, including bulging eyes and double vision. TED is more common in women (16/100,000) compared to men (3/100,000). The risk of getting TED increases in smokers.

TED begins in an active phase, which is marked with progressive inflammation and swelling of the tissues around the eye. Eyes may feel gritty or watery. The patient may experience misalignment of the eyes, bloody, inflamed, watery eyes and an intolerance to bright light. A very noticeable symptom can be proptosis, when the eyes bulge out of their sockets. This active phase is followed by an inactive phase, when disease progression has stopped. The symptoms remain and the disability continues, however.1

Current treatment

When the condition is in its active phase, high-dose glucocorticoids alone  or with radiotherapy may reduce inflammation-related signs and symptoms. Glucocorticoids/radiotherapy minimally affect proptosis (bulging of the eyes). This treatment is only effective during the active phase. During the inactive phase, a patient is not responsive to pharmacotherapy and can only be treated with rehabilitative surgery.1

Tepezza overview:2-4

Tepezza is the first FDA-approved treatment specifically for TED.

Tepezza is a fully human monoclonal antibody, and a targeted inhibitor of the insulin-like growth factor-1 receptor. It is administered to patients via intravenous (IV) infusion once every three weeks for a total of eight infusions over six months.

FDA Advisory Committee Meeting:5 The Dermatologic and Ophthalmic Drugs FDA Advisory Committee voted unanimously (12-0) that Tepezza demonstrated a positive benefit/risk profile. The panelists noted the small efficacy and safety database, however, so they emphasized the need for post-approval studies.

Horizon launched Tepezza at a wholesale acquisition cost (WAC) of approximately $447,000 for the eight infusions (weight-based dosing for an 80 kg patient, $14,900 per single-use 500 mg vial, approximately 30 vials).2-4

Date approved: January 20, 2020
Benefit: Medical benefit

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References

1. Thyroid Eye Disease. Rare Disease Database. Rare Disease Database, Accessed Aug 7, 2020. https://rarediseases.org/rare-diseases/thyroid-eye-disease/

2. Horizontherapeutics.com FDA approves Tepezza (teprotumumab-trbw) for the treatment of thyroid eye disease. Accessed in January 2020 at: https://ir.horizontherapeutics.com/news-releases/news-release-details/fda-approves-tepezzatm-teprotumumab-trbw-treatment-thyroid-eye

3. Fiercepharma.com Horizon notches blockbuster FDA approval for rare eye disease med Tepezza. Accessed in January 2020. https://www.fiercepharma.com/pharma/horizon-notches-fda-approval-for-rare-eye-disease-med-tepezza

4. FDA hands off its latest whirlwind drug OK as Horizon hustles would-be blockbuster to the market. Accessed in January 2020 at: https://endpts.com/fda-hands-off-its-latest-whirlwind-drug-ok-as-horizon-hustles-would-be-blockbuster-to-the-market/

5. Horizon’s eye drug teprotumumab wins FDA panel backing in unanimous vote. Accessed in January 2020 at: https://www.fiercebiotech.com/biotech/a-unanimous-vote-fda-panel-greenlights-horizon-s-eye-drug-teprotumumab

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