FDA approves Horizon’s drug for thyroid eye disease

(Reuters) – The U.S. Food and Drug Administration has approved Horizon Therapeutics Plc’s treatment for thyroid eye disease, the agency said on Tuesday.

The decision makes teprotumumab the first approved treatment for the vision-threatening autoimmune disorder, in which the muscles and fatty tissue behind the eye become inflamed and expand.

The drug could spare patients from needing multiple invasive surgeries by providing an alternative, non-surgical treatment option, the FDA said.

Teprotumumab is expected to further benefit Horizon’s best-performing unit that focuses on rare conditions and made up for nearly three-quarters of its latest quarterly revenue.

The company last week raised its expectations for peak U.S. annual net sales to more than $1 billion from the prior forecast of more than $750 million.

Thyroid eye disease usually occurs in people with Graves’ disease, an immune system disorder that results in overproduction of thyroid hormones.

It begins with an active phase that may last for up to three years, after which damage to the eyes can be irreversible.

As it progresses, the disease causes double vision, bulging of the eye and misalignment, severely affecting the quality of life of patients.

An estimated 15,000 to 20,000 patients in the United States suffer from moderate to severe forms of the disease in the active phase.

Teprotumumab targets the disease in the active phase, and significantly reduced bulging of the eye in patients who were part of the clinical trials.

In December, an FDA expert panel had unanimously voted in favor of the treatment.

Horizon said it was evaluating additional indications for teprotumumab and plans to start an exploratory study on its application in treating diffuse cutaneous scleroderma, a rare skin disease with no treatment options.

Reporting by Vishwadha Chander and Dania Nadeem; Editing by Arun Koyyur

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