FTC to Allow Tepezza Manufacturer to be Bought By Amgen Amid Growing Hearing Loss Litigation

The deal seeks to prevent Amgen from leveraging its near-monopoly on Tepezza and other Horizon drugs into an overwhelming competitive advantage.

Federal regulators say they will allow Amgen, Inc. to buy Horizon Pharmaceuticals, the makers of Tepezza, after the company agreed to a consent decree that limits how it markets and sells drugs, as part of an effort to prevent the company from gaining an overwhelming market advantage.

In December, Amgen announced it had agreed to acquire Horizon for about $28 billion. However, the Federal Trade Commission (FTC) filed a lawsuit in May, objecting to the merger.

The FTC lawsuit claimed giving Amgen control of Horizon’s portfolio of drugs, particularly the thyroid eye disease (TED) drug Tepezza, and the chronic refractory gout (CRG) drug Krystexxa, would “substantially lessening competition in the markets for the sale of FDA-approved drugs to treat TED and CRG”, which could lead to Amgen having a monopoly on drugs that treat those conditions.

Investors have also expressed concerns over the deal, as it comes as Horizon faces a growing number of Tepezza lawsuits, involving claims that the drug has caused users to suffer irreversible hearing loss. Plaintiffs in those claims allege that Horizon knew or should have known about the risk, but withheld critical safety warnings and information from the medical community and patients.

In a press release published on September 1, the FTC announced it was withdrawing its objections to the deal, indicating that Amgen had agreed to a proposed consent order (PDF) which seeks to prevent the company from leveraging a near monopoly on certain drugs, which would harm both competition and consumers.

The consent order prevents Amgen from acquiring any products or stakes in businesses that manufacture or sell any other thyroid eye disease or chronic refractory gout treatments unless it receives approval from the FTC first. This also applies to pre-commercial products which have gone through clinical trials.

Amgen will have to receive FTC approval for any such activities at least through 2032, according to the order. It must also agree to specific monitoring over its use and marketing of Tepezza and Krystexxa for the next 15 years, among other measures.

The consent order also prevents Amgen from cross-bundling the drugs or engaging in exclusionary rebating, which could allow Amgen to force distributors to buy its other drugs if they want access to Tepezza or Krystexxa.

The Commission voted 3-0 in approval of the deal, saying it will help prevent Amgen from running roughshod over competitors and patients who need either of the medications.

“Consolidation in the pharmaceutical industry has given companies the power and incentive to engage in exclusionary rebating practices, which can lead to sky-rocketing prices on essential medications,” Henry Liu, Director of the FTC’s Bureau of Competition, said in the press release. “Today’s proposed resolution sends a clear signal that the FTC and its state partners will scrutinize pharmaceutical mergers that enable such practices, and defend patients and competition in this vital marketplace.”

Tepezza Hearing Loss Lawsuits

Tepezza (teprotumumab-trbw) is a new-generation biologic treatment introduced by Horizon Therapeutics in January 2020, as the first medication approved to treat 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.

Although Tepezza infusions were 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 hearing loss side effects 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.

The U.S. Food and Drug Administration (FDA) recently released a new version of the Tepezza prescribing information guide, which now adds many of the same hearing loss warnings plaintiffs indicate should have been included when the drug was first introduced.

The new Tepezza label update now discloses that users have been left with severe and permanent hearing loss. It also indicates doctors should assess patients’ hearing before, during, and after Tepezza infusions, to avoid users experiencing permanent ear damage.

Given common questions of fact and law raised in complaints filed in federal courts nationwide, a Tepezza MDL (multidistrict litigation) was established in July, centralizing the lawsuits before U.S. District Judge Thomas Durkin in the Northern District of Illinois for coordinated discovery and pretrial proceedings. He is expected to schedule a series of bellwether early test trials to gauge jurors reactions to evidence and testimony likely to be presented in hundreds, potentially thousands, of Tepezza lawsuits.

While the outcome of Tepezza bellwether early trial dates will not be binding on other claims in the litigation, the average lawsuit payouts may influence eventual Tepezza settlement negotiations that will be necessary to avoid each individual case being set for trial in the coming years.