Horizon Therapeutics is trying to shed its reputation as a primary care drugmaker and emerge with a brand-new life in rare diseases. Now, with an FDA approval for a hotly anticipated rare disease med in hand, Horizon’s rebrand is well on its way—and to hear the company tell it, it’ll report blockbuster sales soon enough, with the help of a $14,900-per-vial list price.
The FDA on Tuesday approved Horizon’s Tepezza (teprotumumab) as a treatment for thyroid eye disease (TED), a rare autoimmune disorder that can lead to blurred or double vision. It previously had no approved therapies. Horizon said the drug will launch immediately at a list price of about $200,000 for a six-month course of treatment.
Tepezza is the first drug Horizon has shepherded through the FDA’s Biologics License Application process, “a key step in our evolution to an innovation-focused biopharma company,” CEO Tim Walbert said in a statement.
The FDA based its approval on phase 3 data showing 82.9% of Tepezza patients achieved a 2-mm or greater reduction in proptosis––or eye bulging––after 24 weeks compared with 9.5% of placebo patients. The drug also showed it could reduce clinical symptoms, ease double vision and improve patients’ quality of life.
Based on those results—and a U.S. market of 15,000 to 20,000 patients—Horizon’s predicting blockbuster-level sales for its new med. TED patients typically seek treatment when they notice their eyes bulging in photos or that their eyes and eyelids constantly seem to be red and swollen.
Horizon expects to launch a post-marketing safety and retreatment study for Tepezza pending discussions with the FDA on a possible trial’s structure.
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