Amgen to Seek European OK of Thyroid Eye Disease Drug Tepezza

By Colin Kellaher

Amgen plans to seek European regulatory approval for the sale of its blockbuster Tepezza treatment for thyroid eye disease.

The Thousand Oaks, Calif., biotechnology company on Friday said it is planning an imminent submission of a marketing authorization application to the European Medicines Agency for teprotumumab, as Tepezza is known generically, to treat moderate to severe thyroid eye disease in adults.

There are currently no approved treatments in Europe for thyroid eye disease, a condition that causes bulging eyes and double vision.

Tepezza is the bestselling drug of Horizon Therapeutics, which Amgen acquired last October in a $27.8 billion deal after fending off a challenge from U.S. antitrust regulators. The U.S. Food and Drug Administration approved Tepezza in early 2020.

Amgen reported Tepezza sales of $448 million from Oct. 6, the date of the Horizon deal closing, through the end of 2023.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

April 26, 2024 09:37 ET (13:37 GMT)

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