THOUSAND OAKS, Calif., April 26, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the imminent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for teprotumumab, a fully human monoclonal antibody and targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R), for the treatment of moderate to severe Thyroid Eye Disease (TED) in adults. TED is a serious, progressive, debilitating and potentially vision-threatening autoimmune disease that can cause proptosis (eye bulging), diplopia (double vision), eye pain, redness and swelling.1 If approved, teprotumumab would be the first and only medicine approved for TED in the European Union.
After Amgen completed its $27.8 billion buyout of Horizon Therapeutics in October, executives at the California biotech made it a priority to right the course of thyroid eye disease treatment Tepezza—an instant blockbuster which saw a perplexing slide in just its third full year on the market.
New Analysis Highlights Importance of Adhering to Uninterrupted Full Course of Treatment with TEPEZZA® (teprotumumab-trbw) to Support Thyroid Eye Disease (TED) Patient Outcomes
The FDA recently added a new warning and precaution to the label of Horizon’s blockbuster monoclonal antibody Tepezza (teprotumumab-trbw), which is used as a treatment for thyroid eye disease, to caution patients about the potential for severe hearing-related side effects.
Horizon's Biologic Tepezza (Teprotumumab) Receives Approval in the U.S.
Viridian Therapeutics is trying to carve out a portion of a simmering market for eye disease treatments, releasing phase 1/2 data on a small group of patients that suggests its candidate could rival Amgen-acquired Horizon.
DUBLIN--(BUSINESS WIRE)--Jun. 26, 2023-- Horizon Therapeutics plc (Nasdaq: HZNP) today announced the Brazilian Health Regulatory Agency (ANVISA) has approved TEPEZZA for the treatment of active TED. TEPEZZA is the first and only medicine approved for active TED in Brazil, filling a significant unmet need for those who are living with this progressive autoimmune disease that can threaten vision.
Horizon Therapeutics plc Announces Positive Topline Data from Phase 3 Clinical Trial (OPTIC-J) in Japan Evaluating TEPEZZA® (teprotumumab-trbw) for the Treatment of Active Thyroid Eye Disease (TED)
DUBLIN--(BUSINESS WIRE)--Jun. 17, 2023-- Horizon Therapeutics plc (Nasdaq: HZNP) today announced the presentation of a series of analyses demonstrating the risk of hearing-related events among people with Graves’ disease and TED, including among those treated with TEPEZZA. TEPEZZA is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of TED, regardless of disease activity or duration. TED is a serious, progressive and potentially vision-threatening rare autoimmune disease.1
DUBLIN--(BUSINESS WIRE)--Horizon Therapeutics plc (Nasdaq: HZNP) today announced the presentation of new data from the randomized, double-masked, placebo-controlled Phase 4 clinical trial (NCT04583735) evaluating TEPEZZA in patients with long disease duration and low Clinical Activity Score (CAS), a measure of disease activity. The oral presentation at the Endocrine Society Annual Meeting (ENDO 2023) supports the efficacy and safety of TEPEZZA in TED patients regardless of disease activity or duration. TEPEZZA is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of TED – a serious, progressive, debilitating and potentially vision-threatening rare autoimmune disease.1