FDA OKs Horizon’s teprotumumab for thyroid eye disease

The FDA approves Horizon Therapeutics’ (HZNP -0.4%) Tepezza (teprotumumab-trbw) for the treatment of thyroid eye disease, an Orphan Drug, Priority Review, Fast Track and Breakthrough Therapy indication. The agency’s action date was March 8.

The company will conduct a post-marketing study to assess safety in a larger patient population.

Commercial launch will begin shortly.

Horizon expects to pay ~$105M in milestones in H1. It secured the rights to teprotumumab in 2017 via its $145M acquisition of River Vision Development Corp.

https://seekingalpha.com/news/3533219-fda-oks-horizons-teprotumumab-for-thyroid-eye-disease