trending Market Intelligence /marketintelligence/en/news-insights/trending/hBWrywTh4kiDfW3lrAFMmg2 content
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

In This List

Horizon Therapeutics' autoimmune eye disease drug wins US FDA approval

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry

Segment

IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

The Market Intelligence Platform


Horizon Therapeutics' autoimmune eye disease drug wins US FDA approval

The U.S. Food and Drug Administration approved Horizon Therapeutics PLC's medication for an autoimmune eye disorder.

Dublin-based Horizon's Tepezza, or teprotumumab-trbw, is now approved for treating thyroid eye disease. The drug is expected to be available in the U.S. in the coming weeks.

Thyroid eye disease is common in people with hyperthyroidism or Graves' disease. Patients experience bulging and misalignment of the eyes, blurred or double vision and sometimes blindness.

The regulator's approval comes over a month before the expected decision date of March 8 and follows a recommendation by an FDA panel that unanimously voted in favor of the drug. The agency previously granted Tepezza the priority review, orphan drug, fast-track and breakthrough therapy designations aiming to speed up the regulatory process.

The FDA's approval is supported by data from a phase 2 study, as well as a phase 3 study, dubbed Optic. Results from the trial showed that Tepezza reduced bulging of the eye in 82.9% of patients compared to 9.5% of patients on placebo. The drug also maintained its effectiveness in patients for about a year after the treatment.

Tepezza is a monoclonal antibody, meaning it is derived from identical immune cells to target a specific antigen. It targets the insulin-like growth factor 1 receptor that is overexpressed in thyroid eye disease, causing inflammation and tissue expansion behind the eyes.

Horizon plans a post-marketing study to evaluate Tepezza's safety in a larger population. Additionally, Horizon is eligible for milestone payments in lieu of the drug's approval. It expects to receive $105 million during the first half of 2020.