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12.07.2024 14:48:01 - dpa-AFX: AbbVie Seeking FDA And EMA Approval For Upadacitinib In Giant Cell Arteritis
WASHINGTON (dpa-AFX) - AbbVie, Inc. (ABBV) announced Friday that it has
submitted applications for a new indication to the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA) for upadacitinib
(RINVOQ 15 mg, once daily) for the treatment of adult patients with giant cell
arteritis (GCA).
GCA is an autoimmune disease of medium and large arteries and can cause
headache, jaw pain, and changes in vision, including sudden and permanent loss
of vision.
The regulatory submissions to the FDA and EMA are supported by previously
announced results from the SELECT-GCA Phase 3 study evaluating the safety and
efficacy of upadacitinib in patients with GCA.
Copyright(c) 2024 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
submitted applications for a new indication to the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA) for upadacitinib
(RINVOQ 15 mg, once daily) for the treatment of adult patients with giant cell
arteritis (GCA).
GCA is an autoimmune disease of medium and large arteries and can cause
headache, jaw pain, and changes in vision, including sudden and permanent loss
of vision.
The regulatory submissions to the FDA and EMA are supported by previously
announced results from the SELECT-GCA Phase 3 study evaluating the safety and
efficacy of upadacitinib in patients with GCA.
Copyright(c) 2024 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
| Name | WKN | Börse | Kurs | Datum/Zeit | Diff. | Diff. % | Geld | Brief | Erster | Schluss | |
|---|---|---|---|---|---|---|---|---|---|---|---|
 |
ABBVIE INC. DL-,01 | A1J84E | Frankfurt | 171,920 | 02.08.24 17:03:15 | -4,760 | -2,69% | 0,000 | 0,000 | 173,800 | 171,920 |
