![]() ![]() It really shed light on the importance of the work that we do every day. To hear first-hand what these people had gone through to get the right diagnosis to their approach to tackling daily activities being visually impaired to finding, or in some cases, not finding treatment was both inspiring and heartbreaking. The emotion-filled testimony truly highlighted the dire need for new treatments and the struggle that many people impacted go through on a daily basis. There were more than 10 people who spoke at the open public hearing, including three women who had participated in the TEPEZZA Phase 2 clinical trial. As part of this day-long committee meeting, there is an open public hearing where members of the community, in this case people impacted by TED and advocates, have the opportunity to address the panel. ![]() When a company submits an application for a new medicine to the FDA, it is common for a committee of experts to review the application in a public forum. Food and Drug Administration’s (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee met to review the Biologics License Application for TEPEZZA. This type of partnership and collaboration should be emulated in other disease areas. The physician and advocacy communities were highly collaborative and supportive, which helped make the trial a success. Our clinical team was highly motivated to bring a new treatment to people impacted by TED. We began the Phase 3 clinical trial in October 2017 and because this particular disease state had no FDA-approved treatment, what really stood out for me throughout the duration of the clinical trial was the collaboration within the TED community. As TED progresses, characteristics may include: eye bulging (proptosis), misalignment of the eyes (strabismus) reported in more than 50 percent of people with TED, double vision (diplopia) reported in about 50 percent of people with TED and vision loss. For background, TED is a serious, progressive, vision threatening autoimmune disease, which is most often seen in patients with Graves’ disease. In May 2017, we acquired a company called River Vision and with it, an investigational medicine called teprotumumab (now marketed as TEPEZZA) that was being studied for a rare disease called Thyroid Eye Disease (TED). Freising.The story of the approval of our new breakthrough orphan medicine and the process involved in bringing it to market makes me proud of what we do at Horizon. "Press Release: Horizon Pharma plc and XL-protein GmbH Have Entered Into a Collaboration Agreement on a Potential Next-Generation Biologic for Uncontrolled Gout Using PASylation Technology". "Press Release: Advicenne Appoints Linda Law, MD as US Vice President, Clinical Development and Medical Affairs". "Press Release: FDA Approves Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED)". to Significantly Expand Development Pipeline and Grow Rare Disease Medicine Portfolio". "Press Release: Horizon Therapeutics plc to Acquire Viela Bio, Inc. Amgen Inc to Acquire Horizon Therapeutics plc". More documents for Horizon Therapeutics (Group) (Tim) (Horizon Pharma 201003– CEO before IDM Pharma CEO before NeoPharm + Abbott) The Company's strategy is to develop, acquire or in-license additional innovative medicines where it can execute a targeted commercial approach among specific target physicians while taking advantage of its commercial strengths and the infrastructure the Company has put in place. The Company markets DUEXIS® and RAYOS®/LODOTRA® and will market VIMOVO®, which target unmet therapeutic needs in arthritis, pain and inflammatory diseases. is a specialty pharmaceutical company that has developed and is commercializing products to primary care, orthopedic surgeons and rheumatologists. ![]()
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