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When was Tepezza approved by the FDA?

In January 2020, the U.S. Food and Drug Administration (FDA) approved Tepezza. Tepezza (also known as teprotumumab) is the only drug approved by the FDA to treat thyroid eye disease (TED).

Thyroid eye disease (often mentioned as Grave’s eye disease) is an autoimmune disease linked to hyperthyroidism, a condition in which the thyroid gland is overactive.

Failure of Horizon Pharmaceuticals to accurately warn Tepezza users about associated hearing loss risks

TED is a rare condition, a progressive autoimmune disorder for which, before January 2020, there was no FDA-approved treatment drug. Tepezza appeared on the market as a promising new drug that could offer relief for patients suffering from TED. In cases similar to Tepezza, where a drug might be an effective treatment for a rare condition, the FDA approves the drug with an “orphan status”.

The “orphan status” permits a sped-up availability of the drug on the market by facilitating a faster approval process but does not exempt the manufacturer from the responsibility of accurate warning regarding the adverse effects of the drug and the health damages involved with its usage.

Horizon Pharmaceuticals, the manufacturer of Tepezza, conducted two clinical trials prior to the drug being approved by the FDA. Based on the findings of these clinical trials, the manufacturer warned that hearing loss risks as adverse effects of Tepezza infusions may occur in about 10% of the patients. The main issue and the base of Tepezza claims are that Tepezza infusions are linked to hearing loss and other hearing-related symptoms in a significantly higher percentage of Tepezza users: up to 65%.

The link between an alarmingly high probability of developing otologic symptoms and the Tepezza infusion treatment was first revealed in a study conducted by a group of researchers at Stanford University and presented at the annual meeting of the Endocrine Society in January 2021.

Tepezza-related hearing loss issues were reported by the manufacturer as being non-typical and reversible

Adverse otologic effects of the Tepezza infusion treatment include:

Reported by the manufactured as being non-typical and reversible (meaning that they would improve or disappear in a period of several months after the Tepezza infusion treatment was concluded), these symptoms were shown by the Stanford University study to appear in a high percentage of the patients (up to 65%), with some of them being irreversible.

Permanent hearing loss drastically changes the quality of life of the Tepezza patient and affects to a great degree the ability to work or study.

In case you fulfill the two criteria below, contact our team at Atraxia Law to learn more about your options:

How Atraxia Law can help you with your Tepezza-related hearing loss

If you received several Tepezza infusions and are currently suffering from hearing loss (or other otologic symptoms) as a result, you might be entitled to compensation by filing a Tepezza claim. The first priority is to determine your eligibility. Our team at Atraxia Law will carefully go through every detail and thoroughly analyze your case, and as soon as your eligibility is established, will refer you to an attorney or law firm best fitted for your needs.