(Reuters) – Independent advisers to the U.S. Food and Drug Administration on Friday voted unanimously in favor of Horizon Therapeutics Plc’s experimental treatment for thyroid eye disease (TED), taking the drug a step towards potential approval.
If approved, teprotumumab, a type of immunotherapy, is expected to become a standard of care for the vision-threatening autoimmune disorder, which currently has no approved therapies.
The panel voted 12-0, when asked if the treatment’s benefits outweighed its risks considering it caters to an unmet need.
Thyroid eye disease (TED) usually occurs in people with Graves’ disease, an immune system disorder that results in overproduction of thyroid hormones. TED begins with an active phase that may last for up to three years, after which damage to the eyes can be irreversible.
With the FDA’s blessing, Horizon will be able to tap into a market with an estimated 15,000 to 20,000 patients suffering from moderate to severe forms of the disease.
The addition of teprotumumab, which analysts expect could bring in U.S. sales of over $700 million at peak, is expected to expand Horizon’s best-performing unit that made up nearly three-quarters of its revenue in the latest reported quarter.
The unit focuses on treatments for rare conditions.
The FDA is expected to make a final decision on the treatment’s approval by March 8, 2020. While the agency is not bound to follow the recommendation of its advisory panels, it usually does so.
Reporting by Vishwadha Chander and Manojna Maddipatla in Bengaluru; Editing by Maju Samuel and Shailesh Kuber