After market close on Tuesday, Irish drug company Horizon Therapeutics (HZNP) received a nice surprise from the Food and Drug Administration (FDA). The company's drug Tepezza was approved earlier than expected. This is the first therapy that will hit the market for thyroid eye disease (TED), a rare condition caused by an autoimmune disorder.
TED, which is sometimes referred to as Graves' Eye Disease, can range from mild to severe. It's marked by an inflammation in the eye muscles, eyelids, tear glands and fatty tissues of the eye, which causes them to become red, swollen, and uncomfortable. Approximately one million Americans are diagnosed with the condition each year, with women five times more likely to suffer from it than men.
Horizon's stock has barely moved this week, despite the good news from the FDA. However, the pharmaceutical stock has already had a significant run-up throughout 2019, jumping up about 75% over the last year. The Irish drug company has a $7 billion market cap, and has a significant number of drugs that have had FDA approval (Tepezza will be number ten).
"Today is a great day for people living with Thyroid Eye Disease, a rare, vision-threatening disease that previously had no FDA-approved treatment options," said Timothy Walbert, chairman, president and chief executive officer of Horizon.
This FDA approval was the company's first approval based on a Biologics License Application. Walbert said the BLA is "a key step in our evolution to an innovation-focused biopharma company, developing new medicines for debilitating diseases with few or no treatment options."