FDA Approves Tepezza For Wide Use To Treat Thyroid Eye Disease (TED), Amid Reports of Irreversible Hearing Damage

The updated Tepezza label could significantly expand use of the thyroid eye disease treatment, even as lawsuits are being pursued over failure to warn about the hearing damage risks

As Horizon Therapeutics faces a growing number of Tepezza lawsuits, alleging that users were not adequately warned about the risk of irreversible hearing damage, the drug maker is pushing for wider use of the infusion treatment for thyroid eye disease (TED).

In a press release issued on April 14, the Tepezza manufacturer announced that the U.S. Food and Drug Administration (FDA) has granted approval for Tepezza to be used by a wider number of individuals.

Tepezza (teprotumumab-trbw) is a new-generation biologic treatment introduced in January 2020, as the first medication approved for thyroid eye disease, or bulging eyes, which is caused by hyperthyroidism and linked to Graves’ disease, resulting in inflammation of eye muscles, eyelids, tear glands and fatty tissues behind the eye.

Originally, the FDA approved Tepezza for treatment of Thyroid Eye Disease among individuals who had the disease for nine months or less. The updated labeling approves Tepezza for the treatment of the disease for all patients, regardless of how long they have been experiencing the condition.

Tepezza Failure to Warn Lawsuits

The expanded FDA Tepezza approval comes as the drug maker already faces criticism for over-promoting the thyroid eye disease treatment, and withholding information from users and the medical community about the risk of long-term hearing loss or tinnitus.

Although Tepezza was originally intended as a niche treatment, with only a limited market, during the second year the drug was on the market in the United States sales doubled to $1.66 billion, and critics have expressed concern that Tepezza was aggressively marketed without adequately disclosing all of the potential risks.

Hundreds of former users are now coming forward to report that they experienced various forms of hearing problems from Tepezza, including persistent ringing in the ears known as tinnitus, and complete hearing loss. In many cases, the problems persist long after the thyroid eye disease treatments, leaving users with irreversible hearing damage.

According to allegations raised in recently filed product liability lawsuits over Tepezza, plaintiffs indicate that they may have avoided irreversible hearing damage if the drug maker had warned users and doctors about the importance of reporting symptoms of hearing loss, and conducting audiological monitoring during the treatments.

Updated Tepezza Label

The expanded indications now approved on the Tepezza label follow the results of a clinical trial, which showed the drug to be effective in treating patients who had thyroid eye disease for between two and 10 years. The results are preliminary, however, and have not yet been published in a peer-reviewed medical journal.

The FDA’s label update specifies that Tepezza is now approved for the treatment of thyroid eye disease regardless of how long the patient has had the disease or the number of adverse events the patient has experienced from the condition.

The label update is likely to expand the willingness of doctors to prescribe the drug to their patients and gives Horizon the ability to legally market the drug to virtually anyone with thyroid eye disease.

April 2023 Tepezza Hearing Loss Lawsuit Update

Given common questions of fact and law raised in Tepezza hearing loss lawsuits filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) has been asked to centralize the claims before one judge for coordinated discovery and pretrial proceedings, as part of a Tepezza MDL, or multidistrict litigation.

Each of the lawsuits claim Horizon Therapeutics, the manufacturer, should have been aware of the link between Tepezza and hearing loss before it was ever submitted to U.S. regulators for review, since the drug impacts the insulin-like growth factor I, which is known to play a central role in hearing and low levels have been shown to correlate with human syndromes associated with hearing loss. However, plaintiffs say the drug maker failed to adequately test Tepezza, ignored pose marketing reports that clearly indicated users were experiencing hearing loss, and provided false and misleading information about the safety risks with Tepezza, according to the complaints.

In complex pharmaceutical litigation, where large numbers of claims are brought by users of the same medication or medical product, each experiencing the same or similar injuries, it is common for the U.S. JPML to centralize the litigation to reduce duplicative discovery into common issues that will arise in all claims, avoid conflicting pretrial rulings and to serve the convenience of certain witnesses and parties who will be required to testify in each of the lawsuits.

As Tepezza injury lawyers continue to review and file claims for individuals who experienced hearing problems after receiving the thyroid eye disease treatment, it is ultimately expected that several hundred claims will be brought throughout the federal court system. If an MDL is established, each individual claim may later be remanded back to the U.S. District Court where it was originally filed for trial, if the parties fail to negotiate Tepezza settlements or another resolution for the claims.

The JPML has indicated it will hear oral arguments on Tepezza lawsuit consolidation at a hearing in late May.