FDA Advisory Committee Votes Unanimously to Support the Use of Teprotumumab for the Treatment of Thyroid Eye Disease (TED)
Horizon Therapeutics Public Limited Company - Ordinary Shares (HZNP)
Last horizon therapeutics public limited company - ordinary shares earnings: 2/26 07:00 am
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Source: Business Wire
-- If approved, teprotumumab would be the first and only approved medicine for people living with TED, fulfilling a significant unmet need -- DUBLIN--(BUSINESS WIRE)--Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Administration (FDA) voted unanimously that the potential benefits of teprotumumab, a fully human monoclonal antibody (mAb), outweigh the potential risks for the treatment of Thyroid Eye Disease (TED).TED is a rare, serious, progressive and vision-threatening autoimmune disease, and is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain and facial disfigurement that can significantly impact patients’ quality of life. If approved, teprotumumab would be the first FDA-approved medicine for TED. Teprotumumab is an investigational medicine and its safety and efficacy have not been established.“Today’s unanimously positive vote marks a sig
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